Testimonials

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Quality Systems

Internal Audits

FDA Submissions

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FDA 483 and Warning Letter Resolution

General

Recalls and Safety Alerts

Adverse Event Reporting

GMP Training

Design Controls / Product Development

Regulatory Compliance Manager,

,
“…The [EU MDR] gap assessment was great! It really helped me methodically work through each item to ensure that everything got done correctly and timely. The amount of work and detail you put into it certainly made my life much easier...”
Regulatory Compliance Manager
1700-01-01krandallca
“…The [EU MDR] gap assessment was great! It really helped me methodically work through each item to ensure that everything got done correctly and timely. The amount of work and detail you put into it certainly made my life much easier...”
Regulatory Compliance ManagerRegulatory Compliance Manager
55stars
“…The [EU MDR] gap assessment was great! It really helped me methodically work through each item to ensure that everything got done correctly and timely. The amount of work and detail you put into it certainly made my life much easier...”
Regulatory Compliance Manager,

,
"...[the EU MDR reviewer] has completed their review of the technical documentation and didn’t request any revisions! Sounds like it shouldn’t be long before we get our approval to ship to the EU! Thanks Kevin for the excellent work! [The EU MDR reviewer] originally told me they usually have 2-3 rounds of revisions, but we didn’t have any!"
Regulatory Compliance Manager
1750-01-01krandallca
"...[the EU MDR reviewer] has completed their review of the technical documentation and didn’t request any revisions! Sounds like it shouldn’t be long before we get our approval to ship to the EU! Thanks Kevin for the excellent work! [The EU MDR reviewer] originally told me they usually have 2-3 rounds of revisions, but we didn’t have any!"
Regulatory Compliance ManagerRegulatory Compliance Manager
55stars
"...[the EU MDR reviewer] has completed their review of the technical documentation and didn’t request any revisions! Sounds like it shouldn’t be long before we get our approval to ship to the EU! Thanks Kevin for the excellent work! [The EU MDR reviewer] originally told me they usually have 2-3 rounds of revisions, but we didn’t have any!"
Manager, Regulatory Compliance,

,
"...the [EU MDR technical documentation] boilerplates were perfect and so much better than what we had previously. They made it very easy for me to “fill in the blanks”, as well as end up with one concise, easy to manage, document instead of the hodgepodge of documents we previously had in our MDD tech files. I had no dislikes..."
Manager, Regulatory Compliance
1800-01-01krandallca
"...the [EU MDR technical documentation] boilerplates were perfect and so much better than what we had previously. They made it very easy for me to “fill in the blanks”, as well as end up with one concise, easy to manage, document instead of the hodgepodge of documents we previously had in our MDD tech files. I had no dislikes..."
Manager, Regulatory ComplianceManager, Regulatory Compliance
55stars
"...the [EU MDR technical documentation] boilerplates were perfect and so much better than what we had previously. They made it very easy for me to “fill in the blanks”, as well as end up with one concise, easy to manage, document instead of the hodgepodge of documents we previously had in our MDD tech files. I had no dislikes..."
President,

,
"...Good news, I passed the [EU MDR] “Audit” for my technical files...thanks for your work on this..."
President
1900-01-01krandallca
"...Good news, I passed the [EU MDR] “Audit” for my technical files...thanks for your work on this..."
PresidentPresident
55stars
"...Good news, I passed the [EU MDR] “Audit” for my technical files...thanks for your work on this..."
President,

,
"...This [EU MDR Gap assessment] is an amazing work..."
President
1900-01-01krandallca
"...This [EU MDR Gap assessment] is an amazing work..."
PresidentPresident
55stars
"...This [EU MDR Gap assessment] is an amazing work..."
President,

,
"...Wow, your [EU MDR Technical Documentation] work is yet epic again. Much appreciated and that completes my file...Thanks and whew!"
President
1900-01-01krandallca
"...Wow, your [EU MDR Technical Documentation] work is yet epic again. Much appreciated and that completes my file...Thanks and whew!"
PresidentPresident
55stars
"...Wow, your [EU MDR Technical Documentation] work is yet epic again. Much appreciated and that completes my file...Thanks and whew!"
President,

,
"...I was very impressed with the EU MDR Clinical Evaluation Report, by the way. Great job..."
President
1900-01-01krandallca
"...I was very impressed with the EU MDR Clinical Evaluation Report, by the way. Great job..."
PresidentPresident
55stars
"...I was very impressed with the EU MDR Clinical Evaluation Report, by the way. Great job..."
Chief Operating Officer,

,
"...We really appreciate your work. Looking forward to an EU MDR invoice. As always, thank you for everything..."
Chief Operating Officer
1900-01-01krandallca
"...We really appreciate your work. Looking forward to an EU MDR invoice. As always, thank you for everything..."
Chief Operating OfficerChief Operating Officer
55stars
"...We really appreciate your work. Looking forward to an EU MDR invoice. As always, thank you for everything..."
Precision Device Manufacturer,

,
"...Kevin Randall with Compliance Acuity, has been used for the last 3 years of quarterly internal audits. He is reasonable and easy to work with; we plan to continue to use him..."
Precision Device Manufacturer
1900-01-01krandallca
"...Kevin Randall with Compliance Acuity, has been used for the last 3 years of quarterly internal audits. He is reasonable and easy to work with; we plan to continue to use him..."
Precision Device ManufacturerPrecision Device Manufacturer
55stars
"...Kevin Randall with Compliance Acuity, has been used for the last 3 years of quarterly internal audits. He is reasonable and easy to work with; we plan to continue to use him..."
Regulatory Compliance Manager,

,
“…The EU MDR SOPs were great and much appreciated. With all the labeling work that I had to do, it would have been very easy for me to just overlook the SOPs or to make them so generic that they wouldn’t be useful....”
Regulatory Compliance Manager
1900-01-01krandallca
“…The EU MDR SOPs were great and much appreciated. With all the labeling work that I had to do, it would have been very easy for me to just overlook the SOPs or to make them so generic that they wouldn’t be useful....”
Regulatory Compliance ManagerRegulatory Compliance Manager
55stars
“…The EU MDR SOPs were great and much appreciated. With all the labeling work that I had to do, it would have been very easy for me to just overlook the SOPs or to make them so generic that they wouldn’t be useful....”
President, Chief Engineer – Software Device,

,
"...Thanks! This [EU MDR Clinical Evaluation Plan] looks very good..."
President, Chief Engineer – Software Device
1900-01-21krandallca
"...Thanks! This [EU MDR Clinical Evaluation Plan] looks very good..."
President, Chief Engineer – Software DevicePresident, Chief Engineer – Software Device
45stars
"...Thanks! This [EU MDR Clinical Evaluation Plan] looks very good..."
Manager, Regulatory Compliance,

,
“…The [EU MDR] importer/distributor assistance was perfect. There were lots of little details that we wouldn’t have grasped without your help. I know that [operations] especially appreciated it....”
Manager, Regulatory Compliance
1950-01-01krandallca
“…The [EU MDR] importer/distributor assistance was perfect. There were lots of little details that we wouldn’t have grasped without your help. I know that [operations] especially appreciated it....”
Manager, Regulatory ComplianceManager, Regulatory Compliance
55stars
“…The [EU MDR] importer/distributor assistance was perfect. There were lots of little details that we wouldn’t have grasped without your help. I know that [operations] especially appreciated it....”
COO – Class II device Manufacturer,

,
"...Providing not only the answer, but the reasoning used by regulatory agencies was instrumental not only to our device approval, but to managing the product as a whole..."
COO – Class II device Manufacturer
2001-01-07acuity_admin719
"...Providing not only the answer, but the reasoning used by regulatory agencies was instrumental not only to our device approval, but to managing the product as a whole..."
COO – Class II device ManufacturerCOO – Class II device Manufacturer
55stars
"...Providing not only the answer, but the reasoning used by regulatory agencies was instrumental not only to our device approval, but to managing the product as a whole..."
GMP Training Attendee,

,
“…Kevin committed himself to understanding our business model, products and processes before tailoring training and compliance solutions for our firm. This has been greatly beneficial to our firm from an economic and time perspective as it has built on our systems and processes rather than starting again…”
GMP Training Attendee
2001-01-08acuity_admin719
“…Kevin committed himself to understanding our business model, products and processes before tailoring training and compliance solutions for our firm. This has been greatly beneficial to our firm from an economic and time perspective as it has built on our systems and processes rather than starting again…”
GMP Training AttendeeGMP Training Attendee
55stars
“…Kevin committed himself to understanding our business model, products and processes before tailoring training and compliance solutions for our firm. This has been greatly beneficial to our firm from an economic and time perspective as it has built on our systems and processes rather than starting again…”
President and CEO, Class II device Manufacturer,

,
"...You were able to help me manage the QA and Regulatory functions prior to hiring our own staff. This worked very well. You interfaced well with our engineering staff in addressing our most important Quality Management System issues..."
President and CEO, Class II device Manufacturer
2001-01-14acuity_admin719
"...You were able to help me manage the QA and Regulatory functions prior to hiring our own staff. This worked very well. You interfaced well with our engineering staff in addressing our most important Quality Management System issues..."
President and CEO, Class II device ManufacturerPresident and CEO, Class II device Manufacturer
55stars
"...You were able to help me manage the QA and Regulatory functions prior to hiring our own staff. This worked very well. You interfaced well with our engineering staff in addressing our most important Quality Management System issues..."
Director, Regulatory Affairs and Quality Assurance, Class II devices,

,
“...I will continue to use ComplianceAcuity for our regulatory and quality needs. We have had successful outcomes each time we have used ComplianceAcuity...”
Director, Regulatory Affairs and Quality Assurance, Class II devices
2001-01-22acuity_admin719
“...I will continue to use ComplianceAcuity for our regulatory and quality needs. We have had successful outcomes each time we have used ComplianceAcuity...”
Director, Regulatory Affairs and Quality Assurance, Class II devicesDirector, Regulatory Affairs and Quality Assurance, Class II devices
55stars
“...I will continue to use ComplianceAcuity for our regulatory and quality needs. We have had successful outcomes each time we have used ComplianceAcuity...”
Director, Regulatory Affairs and Quality Assurance,

,
“...From my experience with ComplianceAcuity, I have always observed the highest level of expertise in delivering tailored and practical compliance solutions. For example, Kevin was able to help us remodel our CAPA and data monitoring processes which resulted in a very high level of confidence in our ability to clearly identify when we needed to activate a CAPA and how to justify otherwise. This resulted in our team spending time on the highest priority activities (as recognized by regulators) as compared to our previous prioritization which was causing dilution of our efforts...”
Director, Regulatory Affairs and Quality Assurance
2001-01-23acuity_admin719
“...From my experience with ComplianceAcuity, I have always observed the highest level of expertise in delivering tailored and practical compliance solutions. For example, Kevin was able to help us remodel our CAPA and data monitoring processes which resulted in a very high level of confidence in our ability to clearly identify when we needed to activate a CAPA and how to justify otherwise. This resulted in our team spending time on the highest priority activities (as recognized by regulators) as compared to our previous prioritization which was causing dilution of our efforts...”
Director, Regulatory Affairs and Quality AssuranceDirector, Regulatory Affairs and Quality Assurance
55stars
“...From my experience with ComplianceAcuity, I have always observed the highest level of expertise in delivering tailored and practical compliance solutions. For example, Kevin was able to help us remodel our CAPA and data monitoring processes which resulted in a very high level of confidence in our ability to clearly identify when we needed to activate a CAPA and how to justify otherwise. This resulted in our team spending time on the highest priority activities (as recognized by regulators) as compared to our previous prioritization which was causing dilution of our efforts...”
Director of Development and Manufacturing Operations – Class II device Manufacturer,

,
"...One of the areas in my work to develop company systems with ComplianceAcuity I found most useful was to build a system and then review it with you in detail. This was a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."
Director of Development and Manufacturing Operations – Class II device Manufacturer
2001-01-24acuity_admin719
"...One of the areas in my work to develop company systems with ComplianceAcuity I found most useful was to build a system and then review it with you in detail. This was a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."
Director of Development and Manufacturing Operations – Class II device ManufacturerDirector of Development and Manufacturing Operations – Class II device Manufacturer
45stars
"...One of the areas in my work to develop company systems with ComplianceAcuity I found most useful was to build a system and then review it with you in detail. This was a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."
COO, Class II device Manufacturer,

,
"...Highly professional and very detail oriented...Of all the suppliers I have used over the years, ComplianceAcuity earned my highest recommendation..."
COO, Class II device Manufacturer
2002-01-13acuity_admin719
"...Highly professional and very detail oriented...Of all the suppliers I have used over the years, ComplianceAcuity earned my highest recommendation..."
COO, Class II device ManufacturerCOO, Class II device Manufacturer
55stars
"...Highly professional and very detail oriented...Of all the suppliers I have used over the years, ComplianceAcuity earned my highest recommendation..."
President & CEO, Class II device Manufacturer,

,
"...Your services were customized to the specific needs and constraints of our company instead of providing a canned process that did not fit our business model or intended QMS...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS..."
President & CEO, Class II device Manufacturer
2016-02-01acuity_admin719
"...Your services were customized to the specific needs and constraints of our company instead of providing a canned process that did not fit our business model or intended QMS...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS..."
President & CEO, Class II device ManufacturerPresident & CEO, Class II device Manufacturer
55stars
"...Your services were customized to the specific needs and constraints of our company instead of providing a canned process that did not fit our business model or intended QMS...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS..."
Director, Regulatory Affairs & Quality Assurance, Class II device Manufacturer,

,
“…ComplianceAcuity is the 4th regulatory consultant I have used over the years. By far he has been head and shoulders above the others for the following reasons: 1) Expertise with regulations. Others did not have the breadth and depth of his expertise. 2) Quality of his solutions and ability to tailor to our firm as opposed to other consultants who used 'template-based' solutions. 3) Kevin himself is highly intelligent which enables him to quickly understand our products and processes to enable him to provide appropriate solutions the first time. This is a rare ability. 4) His personal commitment to our company was as high as any of our or our own employees. For example, he made various personal sacrifices to ensure our firm was as best prepared as possible for our recent FDA audit…”
Director, Regulatory Affairs & Quality Assurance, Class II device Manufacturer
2016-02-02acuity_admin719
“…ComplianceAcuity is the 4th regulatory consultant I have used over the years. By far he has been head and shoulders above the others for the following reasons: 1) Expertise with regulations. Others did not have the breadth and depth of his expertise. 2) Quality of his solutions and ability to tailor to our firm as opposed to other consultants who used 'template-based' solutions. 3) Kevin himself is highly intelligent which enables him to quickly understand our products and processes to enable him to provide appropriate solutions the first time. This is a rare ability. 4) His personal commitment to our company was as high as any of our or our own employees. For example, he made various personal sacrifices to ensure our firm was as best prepared as possible for our recent FDA audit…”
Director, Regulatory Affairs & Quality Assurance, Class II device ManufacturerDirector, Regulatory Affairs & Quality Assurance, Class II device Manufacturer
55stars
“…ComplianceAcuity is the 4th regulatory consultant I have used over the years. By far he has been head and shoulders above the others for the following reasons: 1) Expertise with regulations. Others did not have the breadth and depth of his expertise. 2) Quality of his solutions and ability to tailor to our firm as opposed to other consultants who used 'template-based' solutions. 3) Kevin himself is highly intelligent which enables him to quickly understand our products and processes to enable him to provide appropriate solutions the first time. This is a rare ability. 4) His personal commitment to our company was as high as any of our or our own employees. For example, he made various personal sacrifices to ensure our firm was as best prepared as possible for our recent FDA audit…”
Quality Manager,

,
“…Well, [Kevin Randall] is the word smith master. His knowledge of QS regs, principles and processes is exceptional and is able to promptly provide solutions...”
Quality Manager
2016-02-04acuity_admin719
“…Well, [Kevin Randall] is the word smith master. His knowledge of QS regs, principles and processes is exceptional and is able to promptly provide solutions...”
Quality ManagerQuality Manager
55stars
“…Well, [Kevin Randall] is the word smith master. His knowledge of QS regs, principles and processes is exceptional and is able to promptly provide solutions...”
Director of Operations – Class III device Manufacturer & Distributor,

,
“…After a series of unsuccessful FDA inspections resulting in a Warning Letter, ComplianceAcuity was hired to help resolve our longstanding issues. ComplianceAcuity clarified the problems and provided professional solutions where prior consultants, one of which was an “ex-FDAer”, did not. Because of ComplianceAcuity’s services, we were better prepared and achieved a positive outcome when FDA performed a follow-up inspection…“
Director of Operations – Class III device Manufacturer & Distributor
2016-02-06acuity_admin719
“…After a series of unsuccessful FDA inspections resulting in a Warning Letter, ComplianceAcuity was hired to help resolve our longstanding issues. ComplianceAcuity clarified the problems and provided professional solutions where prior consultants, one of which was an “ex-FDAer”, did not. Because of ComplianceAcuity’s services, we were better prepared and achieved a positive outcome when FDA performed a follow-up inspection…“
Director of Operations – Class III device Manufacturer & DistributorDirector of Operations – Class III device Manufacturer & Distributor
55stars
“…After a series of unsuccessful FDA inspections resulting in a Warning Letter, ComplianceAcuity was hired to help resolve our longstanding issues. ComplianceAcuity clarified the problems and provided professional solutions where prior consultants, one of which was an “ex-FDAer”, did not. Because of ComplianceAcuity’s services, we were better prepared and achieved a positive outcome when FDA performed a follow-up inspection…“
CEO – Class II device Manufacturer,

,
“…The bottom line is that, due to ComplianceAcuity's efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I strongly recommend Kevin Randall and his Associates...”
CEO – Class II device Manufacturer
2016-09-28acuity_admin719
“…The bottom line is that, due to ComplianceAcuity's efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I strongly recommend Kevin Randall and his Associates...”
CEO – Class II device ManufacturerCEO – Class II device Manufacturer
55stars
“…The bottom line is that, due to ComplianceAcuity's efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I strongly recommend Kevin Randall and his Associates...”
Director, Regulatory Affairs & Quality Assurance, Class II devices,

,
“…ComplianceAcuity has added considerable value to our company by helping us understand any gaps in our compliance to FDA QS Regulations. Additionally, ComplianceAcuity was able to help us implement practical solutions to bring us in line with best practice. This was demonstrated by our recent FDA audit where previous issues identified by the FDA had now been recognized as being completely addressed....”
Director, Regulatory Affairs & Quality Assurance, Class II devices
2016-09-28acuity_admin719
“…ComplianceAcuity has added considerable value to our company by helping us understand any gaps in our compliance to FDA QS Regulations. Additionally, ComplianceAcuity was able to help us implement practical solutions to bring us in line with best practice. This was demonstrated by our recent FDA audit where previous issues identified by the FDA had now been recognized as being completely addressed....”
Director, Regulatory Affairs & Quality Assurance, Class II devicesDirector, Regulatory Affairs & Quality Assurance, Class II devices
55stars
“…ComplianceAcuity has added considerable value to our company by helping us understand any gaps in our compliance to FDA QS Regulations. Additionally, ComplianceAcuity was able to help us implement practical solutions to bring us in line with best practice. This was demonstrated by our recent FDA audit where previous issues identified by the FDA had now been recognized as being completely addressed....”
President & CEO – Class II device Manufacturer,

,

"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."

President & CEO – Class II device Manufacturer
2016-09-28acuity_admin719
"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."
President & CEO – Class II device ManufacturerPresident & CEO – Class II device Manufacturer
55stars
"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."
Quality Manager, Class II devices,

,
“…Definitely added value. With the gap audit, ComplianceAcuity found many crucial gaps and helped provide high level solutions to fill the gaps. Without the expertise of ComplianceAcuity our last FDA audit would have been a disaster...”
Quality Manager, Class II devices
2016-09-28acuity_admin719
“…Definitely added value. With the gap audit, ComplianceAcuity found many crucial gaps and helped provide high level solutions to fill the gaps. Without the expertise of ComplianceAcuity our last FDA audit would have been a disaster...”
Quality Manager, Class II devicesQuality Manager, Class II devices
55stars
“…Definitely added value. With the gap audit, ComplianceAcuity found many crucial gaps and helped provide high level solutions to fill the gaps. Without the expertise of ComplianceAcuity our last FDA audit would have been a disaster...”
CEO – Class II device Manufacturer,

,
“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance...”
CEO – Class II device Manufacturer
2016-09-28acuity_admin719
“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance...”
CEO – Class II device ManufacturerCEO – Class II device Manufacturer
55stars
“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance...”
COO – Class II device Manufacturer,

,
"... a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."
COO – Class II device Manufacturer
2016-09-28acuity_admin719
"... a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."
COO – Class II device ManufacturerCOO – Class II device Manufacturer
55stars
"... a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."
Customer Service Supervisor – Class II & III device Manufacturer,

,
“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives. Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions. Assisted tremendously in encapsulating the core issues that needed to be resolved so we could be compliant and still efficient...”
Customer Service Supervisor – Class II & III device Manufacturer
2016-09-28acuity_admin719
“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives. Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions. Assisted tremendously in encapsulating the core issues that needed to be resolved so we could be compliant and still efficient...”
Customer Service Supervisor – Class II & III device ManufacturerCustomer Service Supervisor – Class II & III device Manufacturer
55stars
“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives. Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions. Assisted tremendously in encapsulating the core issues that needed to be resolved so we could be compliant and still efficient...”
CEO – Class II device Manufacturer,

,
“…The biggest value ComplianceAcuity brought to the table for us was communication. Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking down difficult issues into palatable ones, and educating our personnel without directing blame or allowing interdepartmental conflicts to interfere with the project. In addition, throughout the project I was kept completely informed by detailed progress reports and daily meetings...”
CEO – Class II device Manufacturer
2016-09-28acuity_admin719
“…The biggest value ComplianceAcuity brought to the table for us was communication. Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking down difficult issues into palatable ones, and educating our personnel without directing blame or allowing interdepartmental conflicts to interfere with the project. In addition, throughout the project I was kept completely informed by detailed progress reports and daily meetings...”
CEO – Class II device ManufacturerCEO – Class II device Manufacturer
55stars
“…The biggest value ComplianceAcuity brought to the table for us was communication. Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking down difficult issues into palatable ones, and educating our personnel without directing blame or allowing interdepartmental conflicts to interfere with the project. In addition, throughout the project I was kept completely informed by detailed progress reports and daily meetings...”
Director of Operations – Class II and III device Manufacturer,

,
“…You are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line...”
Director of Operations – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…You are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line...”
Director of Operations – Class II and III device ManufacturerDirector of Operations – Class II and III device Manufacturer
55stars
“…You are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line...”
President & Founder – Virtual Manufacturer of Class II devices,

,
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”
President & Founder – Virtual Manufacturer of Class II devices
2016-09-28acuity_admin719
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”
President & Founder – Virtual Manufacturer of Class II devicesPresident & Founder – Virtual Manufacturer of Class II devices
55stars
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”
Director of Operations – Class II and III device Manufacturer,

,
“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”
Director of Operations – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”
Director of Operations – Class II and III device ManufacturerDirector of Operations – Class II and III device Manufacturer
55stars
“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”
Director of Operations – Class III device Manufacturer & Distributor,

,
“…ComplianceAcuity taught us how to understand and speak FDA’s language...”
Director of Operations – Class III device Manufacturer & Distributor
2016-09-28acuity_admin719
“…ComplianceAcuity taught us how to understand and speak FDA’s language...”
Director of Operations – Class III device Manufacturer & DistributorDirector of Operations – Class III device Manufacturer & Distributor
55stars
“…ComplianceAcuity taught us how to understand and speak FDA’s language...”
12-year veteran in various positions including Director of Quality,

,

“…The systems you delivered are highly customized to meet our compliance requirements and business needs. All interactions were very professional and goal-oriented. [We] did not have the ‘band-width’ in a couple areas which ComplianceAcuity helped us cover: 1. Compliance and regulatory understanding, was/is not wide-spread. 2. Having the skill sets and time to create Policies/Procedures/Work Instructions. Having [ComplianceAcuity’s] regulatory expertise combined with the documentation skills added immense value since we were trying to run the current system while creating a new one. You certainly brought a high level of expertise and professionalism, mixed with enough humor to keep us all sane!”
Director of Quality – Class II & III device Manufacturer,

,
“…Kevin was very diligent and rigorous in his processing work for the CHS/CAPA system. He talked to all those involved to be sure of his facts so that the system was compliant but also reflected the practice, except where we needed to change it. Kevin also responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”
Director of Quality – Class II & III device Manufacturer
2016-09-28acuity_admin719
“…Kevin was very diligent and rigorous in his processing work for the CHS/CAPA system. He talked to all those involved to be sure of his facts so that the system was compliant but also reflected the practice, except where we needed to change it. Kevin also responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”
Director of Quality – Class II & III device ManufacturerDirector of Quality – Class II & III device Manufacturer
55stars
“…Kevin was very diligent and rigorous in his processing work for the CHS/CAPA system. He talked to all those involved to be sure of his facts so that the system was compliant but also reflected the practice, except where we needed to change it. Kevin also responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”
Sr. Process & Quality Manager,

,
“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”
Sr. Process & Quality Manager
2016-09-28acuity_admin719
“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”
Sr. Process & Quality ManagerSr. Process & Quality Manager
55stars
“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”
Director of Operations – Class III device Manufacturer & Distributor,

,
“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed...”
Director of Operations – Class III device Manufacturer & Distributor
2016-09-28acuity_admin719
“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed...”
Director of Operations – Class III device Manufacturer & DistributorDirector of Operations – Class III device Manufacturer & Distributor
55stars
“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed...”
Quality Assurance Manager – Class II and III device Manufacturer,

,

“…The most immediate benefit of your services is the comprehensive analysis of our company’s quality management system and its level of compliance with FDA and ISO standards. Following the internal audit provided by ComplianceAcuity, the company was aware of where its quality management system was vulnerable and where its resources should be focused...”

Quality Assurance Manager – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…The most immediate benefit of your services is the comprehensive analysis of our company’s quality management system and its level of compliance with FDA and ISO standards. Following the internal audit provided by ComplianceAcuity, the company was aware of where its quality management system was vulnerable and where its resources should be focused...”
Quality Assurance Manager – Class II and III device ManufacturerQuality Assurance Manager – Class II and III device Manufacturer
55stars
“…The most immediate benefit of your services is the comprehensive analysis of our company’s quality management system and its level of compliance with FDA and ISO standards. Following the internal audit provided by ComplianceAcuity, the company was aware of where its quality management system was vulnerable and where its resources should be focused...”
Director of Operations – Class II and III device Manufacturer,

,
“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”
Director of Operations – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”
Director of Operations – Class II and III device ManufacturerDirector of Operations – Class II and III device Manufacturer
55stars
“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”
Sr. QA Manager, Design & Development,

,
“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”
Sr. QA Manager, Design & Development
2016-09-28acuity_admin719
“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”
Sr. QA Manager, Design & DevelopmentSr. QA Manager, Design & Development
55stars
“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”
QA Manager – Class II device Manufacturer,

,
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”
QA Manager – Class II device Manufacturer
2016-09-28acuity_admin719
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”
QA Manager – Class II device ManufacturerQA Manager – Class II device Manufacturer
55stars
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”
Quality Assurance Manager – Class II and III device Manufacturer,

,

“…The internal audit conducted by ComplianceAcuity was comprehensive and practical, with an attention to detail that provided our company insight into our own business that we did not have before. The audit was conducted with intelligence and professionalism, reflecting in depth knowledge and understanding of FDA and ISO...”

Quality Assurance Manager – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…The internal audit conducted by ComplianceAcuity was comprehensive and practical, with an attention to detail that provided our company insight into our own business that we did not have before. The audit was conducted with intelligence and professionalism, reflecting in depth knowledge and understanding of FDA and ISO...”
Quality Assurance Manager – Class II and III device ManufacturerQuality Assurance Manager – Class II and III device Manufacturer
55stars
“…The internal audit conducted by ComplianceAcuity was comprehensive and practical, with an attention to detail that provided our company insight into our own business that we did not have before. The audit was conducted with intelligence and professionalism, reflecting in depth knowledge and understanding of FDA and ISO...”
QA Director and VP of R&D – Virtual Manufacturer of Class III implantable devices,

,
“…We were quite impressed with your abilities...”
QA Director and VP of R&D – Virtual Manufacturer of Class III implantable devices
2016-09-28acuity_admin719
“…We were quite impressed with your abilities...”
QA Director and VP of R&D – Virtual Manufacturer of Class III implantable devicesQA Director and VP of R&D – Virtual Manufacturer of Class III implantable devices
55stars
“…We were quite impressed with your abilities...”
Business Development – Class II Device Virtual Manufacturer,

,

“…I appreciate all the assistance you have provided and look forward to working with you in the future...”

Business Development – Class II Device Virtual Manufacturer
2016-09-28acuity_admin719
“…I appreciate all the assistance you have provided and look forward to working with you in the future...”
Business Development – Class II Device Virtual ManufacturerBusiness Development – Class II Device Virtual Manufacturer
45stars
“…I appreciate all the assistance you have provided and look forward to working with you in the future...”
QA Manager – Class II device Manufacturer,

,
“…ComplianceAcuity ensured that our best interests were always priority #1...”
QA Manager – Class II device Manufacturer
2016-09-28acuity_admin719
“…ComplianceAcuity ensured that our best interests were always priority #1...”
QA Manager – Class II device ManufacturerQA Manager – Class II device Manufacturer
55stars
“…ComplianceAcuity ensured that our best interests were always priority #1...”
Sr. Quality Engineer – Class II & III device Manufacturer,

,
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with...”
Sr. Quality Engineer – Class II & III device Manufacturer
2016-09-28acuity_admin719
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with...”
Sr. Quality Engineer – Class II & III device ManufacturerSr. Quality Engineer – Class II & III device Manufacturer
55stars
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with...”
Sr. QA Manager, Design & Development,

,
“…ComplianceAcuity built a foundation for Design Controls that carry forward to the current time which has made the whole design control effort more sustainable with current head count level. This was chiefly done by mapping the requirements to the final product testing effort...”
Sr. QA Manager, Design & Development
2016-09-28acuity_admin719
“…ComplianceAcuity built a foundation for Design Controls that carry forward to the current time which has made the whole design control effort more sustainable with current head count level. This was chiefly done by mapping the requirements to the final product testing effort...”
Sr. QA Manager, Design & DevelopmentSr. QA Manager, Design & Development
55stars
“…ComplianceAcuity built a foundation for Design Controls that carry forward to the current time which has made the whole design control effort more sustainable with current head count level. This was chiefly done by mapping the requirements to the final product testing effort...”
Senior Process and Quality Manager,

,
“…Awesome job, but we already knew from your on-site work that you are professional, thorough, and willing to help us become a fully compliant and quality-driven supplier of high-performance medical equipment...”
Senior Process and Quality Manager
2016-09-28acuity_admin719
“…Awesome job, but we already knew from your on-site work that you are professional, thorough, and willing to help us become a fully compliant and quality-driven supplier of high-performance medical equipment...”
Senior Process and Quality ManagerSenior Process and Quality Manager
55stars
“…Awesome job, but we already knew from your on-site work that you are professional, thorough, and willing to help us become a fully compliant and quality-driven supplier of high-performance medical equipment...”
Director of Operations – Class III device Manufacturer & Distributor,

,
“…Traditionally our FDA compliance responsibilities have been unclear to us in our unique business model. The explanation that ComplianceAcuity provided to our management team was the most thorough, tactful, and precise that we’ve ever received. FDA has since concurred with ComplianceAcuity’s analysis and we continue to rely on ComplianceAcuity’s insight daily as we operate our business...”
Director of Operations – Class III device Manufacturer & Distributor
2016-09-28acuity_admin719
“…Traditionally our FDA compliance responsibilities have been unclear to us in our unique business model. The explanation that ComplianceAcuity provided to our management team was the most thorough, tactful, and precise that we’ve ever received. FDA has since concurred with ComplianceAcuity’s analysis and we continue to rely on ComplianceAcuity’s insight daily as we operate our business...”
Director of Operations – Class III device Manufacturer & DistributorDirector of Operations – Class III device Manufacturer & Distributor
55stars
“…Traditionally our FDA compliance responsibilities have been unclear to us in our unique business model. The explanation that ComplianceAcuity provided to our management team was the most thorough, tactful, and precise that we’ve ever received. FDA has since concurred with ComplianceAcuity’s analysis and we continue to rely on ComplianceAcuity’s insight daily as we operate our business...”
Director of Operations – Class III device Manufacturer & Distributor,

,
“…ComplianceAcuity’s audit approach was thorough, yet personable, professional, pragmatic and supremely constructive when compared to prior outsourced audits. ComplianceAcuity’s audit findings were educational and informative thereby enabling us to focus our resources in the right places...”
Director of Operations – Class III device Manufacturer & Distributor
2016-09-28acuity_admin719
“…ComplianceAcuity’s audit approach was thorough, yet personable, professional, pragmatic and supremely constructive when compared to prior outsourced audits. ComplianceAcuity’s audit findings were educational and informative thereby enabling us to focus our resources in the right places...”
Director of Operations – Class III device Manufacturer & DistributorDirector of Operations – Class III device Manufacturer & Distributor
55stars
“…ComplianceAcuity’s audit approach was thorough, yet personable, professional, pragmatic and supremely constructive when compared to prior outsourced audits. ComplianceAcuity’s audit findings were educational and informative thereby enabling us to focus our resources in the right places...”
Sr. QA Manager, Design & Development,

,
“…Kevin provided positive critique of our Design Control process that has put us in a better compliance footing with external audits going forward. His foundation-building in this arena has helped the management teams become well prepared and will result in fewer compliance issues…”
Sr. QA Manager, Design & Development
2016-09-28acuity_admin719
“…Kevin provided positive critique of our Design Control process that has put us in a better compliance footing with external audits going forward. His foundation-building in this arena has helped the management teams become well prepared and will result in fewer compliance issues…”
Sr. QA Manager, Design & DevelopmentSr. QA Manager, Design & Development
55stars
“…Kevin provided positive critique of our Design Control process that has put us in a better compliance footing with external audits going forward. His foundation-building in this arena has helped the management teams become well prepared and will result in fewer compliance issues…”
Director of Operations – Class II and III device Manufacturer,

,
“…I have found that you have provided valuable information and guidance during our relationship over the years. You have responded in a timely manner when we need an opinion on regulatory issues and seem to possess a vast knowledge of the Quality System Regulations. Your ability to provide the FDA perspective on various aspects regarding 510k submissions, audits, and other related activities is beneficial to our compliance efforts...”
Director of Operations – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…I have found that you have provided valuable information and guidance during our relationship over the years. You have responded in a timely manner when we need an opinion on regulatory issues and seem to possess a vast knowledge of the Quality System Regulations. Your ability to provide the FDA perspective on various aspects regarding 510k submissions, audits, and other related activities is beneficial to our compliance efforts...”
Director of Operations – Class II and III device ManufacturerDirector of Operations – Class II and III device Manufacturer
55stars
“…I have found that you have provided valuable information and guidance during our relationship over the years. You have responded in a timely manner when we need an opinion on regulatory issues and seem to possess a vast knowledge of the Quality System Regulations. Your ability to provide the FDA perspective on various aspects regarding 510k submissions, audits, and other related activities is beneficial to our compliance efforts...”
Manager, Quality Systems – Class II & III device Manufacturer,

,
“…We were very pleased with Kevin's work. He was very knowledgeable regarding the industry Standards and Regulations. He was provided copies of our company's procedures prior to the scheduled audit and had a good understanding of them in order to perform the audit of our systems and processes. His reports were clear and precise and timely. He was very professional in his dealing with our audit area management teams. We would use Kevin again if needed...”
Manager, Quality Systems – Class II & III device Manufacturer
2016-09-28acuity_admin719
“…We were very pleased with Kevin's work. He was very knowledgeable regarding the industry Standards and Regulations. He was provided copies of our company's procedures prior to the scheduled audit and had a good understanding of them in order to perform the audit of our systems and processes. His reports were clear and precise and timely. He was very professional in his dealing with our audit area management teams. We would use Kevin again if needed...”
Manager, Quality Systems – Class II & III device ManufacturerManager, Quality Systems – Class II & III device Manufacturer
55stars
“…We were very pleased with Kevin's work. He was very knowledgeable regarding the industry Standards and Regulations. He was provided copies of our company's procedures prior to the scheduled audit and had a good understanding of them in order to perform the audit of our systems and processes. His reports were clear and precise and timely. He was very professional in his dealing with our audit area management teams. We would use Kevin again if needed...”
Quality Assurance Manager – Class II and III device Manufacturer,

,
“…A lasting benefit of having ComplianceAcuity conduct an internal audit was the creation of a professional relationship upon which our company can depend for informed, top-quality consulting services when we are faced with an issue beyond the scope of our internal quality personnel’s experiences...”
Quality Assurance Manager – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…A lasting benefit of having ComplianceAcuity conduct an internal audit was the creation of a professional relationship upon which our company can depend for informed, top-quality consulting services when we are faced with an issue beyond the scope of our internal quality personnel’s experiences...”
Quality Assurance Manager – Class II and III device ManufacturerQuality Assurance Manager – Class II and III device Manufacturer
55stars
“…A lasting benefit of having ComplianceAcuity conduct an internal audit was the creation of a professional relationship upon which our company can depend for informed, top-quality consulting services when we are faced with an issue beyond the scope of our internal quality personnel’s experiences...”
Sr. QA Manager, Design & Development,

,
“…with ComplianceAcuity’s track record and thorough understanding of the Design Control regulations…I can fully recommend Kevin’s capable services. I would be happy to have Kevin back...”
Sr. QA Manager, Design & Development
2016-09-28acuity_admin719
“…with ComplianceAcuity’s track record and thorough understanding of the Design Control regulations…I can fully recommend Kevin’s capable services. I would be happy to have Kevin back...”
Sr. QA Manager, Design & DevelopmentSr. QA Manager, Design & Development
55stars
“…with ComplianceAcuity’s track record and thorough understanding of the Design Control regulations…I can fully recommend Kevin’s capable services. I would be happy to have Kevin back...”
QA Manager – Class II device Manufacturer,

,
“…You took a lot of your time to mentor me. I am a more knowledgeable person for it…”
QA Manager – Class II device Manufacturer
2016-09-28acuity_admin719
“…You took a lot of your time to mentor me. I am a more knowledgeable person for it…”
QA Manager – Class II device ManufacturerQA Manager – Class II device Manufacturer
55stars
“…You took a lot of your time to mentor me. I am a more knowledgeable person for it…”
Director of Operations – Class II and III device Manufacturer,

,
“…We were very satisfied with the results. You provided a template that assisted us with the Design History File that was useful to organize our activities. You worked in concert with our QA department to keep the process on task and meet our project deadlines...”
Director of Operations – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…We were very satisfied with the results. You provided a template that assisted us with the Design History File that was useful to organize our activities. You worked in concert with our QA department to keep the process on task and meet our project deadlines...”
Director of Operations – Class II and III device ManufacturerDirector of Operations – Class II and III device Manufacturer
55stars
“…We were very satisfied with the results. You provided a template that assisted us with the Design History File that was useful to organize our activities. You worked in concert with our QA department to keep the process on task and meet our project deadlines...”
QA Manager – Class II and III device Manufacturer,

,
“…Kevin has the knowledge and experience to provide excellent regulatory guidance. Kevin has also provided regulatory guidance regarding import to foreign countries, guidance in shipping into Canada and has done ISO/FDA audits for our company. His knowledge and attention to detail exceeded my expectations. I look forward to working with Kevin on future projects…”
QA Manager – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…Kevin has the knowledge and experience to provide excellent regulatory guidance. Kevin has also provided regulatory guidance regarding import to foreign countries, guidance in shipping into Canada and has done ISO/FDA audits for our company. His knowledge and attention to detail exceeded my expectations. I look forward to working with Kevin on future projects…”
QA Manager – Class II and III device ManufacturerQA Manager – Class II and III device Manufacturer
55stars
“…Kevin has the knowledge and experience to provide excellent regulatory guidance. Kevin has also provided regulatory guidance regarding import to foreign countries, guidance in shipping into Canada and has done ISO/FDA audits for our company. His knowledge and attention to detail exceeded my expectations. I look forward to working with Kevin on future projects…”
Sr. QA Manager, Design & Development,

,
“…Excellent critique was given in the form of design audits that made the design control effort more audit friendly…”
Sr. QA Manager, Design & Development
2016-09-28acuity_admin719
“…Excellent critique was given in the form of design audits that made the design control effort more audit friendly…”
Sr. QA Manager, Design & DevelopmentSr. QA Manager, Design & Development
55stars
“…Excellent critique was given in the form of design audits that made the design control effort more audit friendly…”
Director of Operations – Class II and III device Manufacturer,

,
“…I am confident that your knowledge, contacts in FDA, and your ability to interact with [our] personnel were instrumental in getting our approval rapidly. Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”
Director of Operations – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…I am confident that your knowledge, contacts in FDA, and your ability to interact with [our] personnel were instrumental in getting our approval rapidly. Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”
Director of Operations – Class II and III device ManufacturerDirector of Operations – Class II and III device Manufacturer
55stars
“…I am confident that your knowledge, contacts in FDA, and your ability to interact with [our] personnel were instrumental in getting our approval rapidly. Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”
President & CEO, Class II device Manufacturer,

,
"...The most significant contribution [by ComplianceAcuity] was managing the interface with the FDA to obtain the clearance with a challenging set of circumstances..."
President & CEO, Class II device Manufacturer
2016-09-28acuity_admin719
"...The most significant contribution [by ComplianceAcuity] was managing the interface with the FDA to obtain the clearance with a challenging set of circumstances..."
President & CEO, Class II device ManufacturerPresident & CEO, Class II device Manufacturer
55stars
"...The most significant contribution [by ComplianceAcuity] was managing the interface with the FDA to obtain the clearance with a challenging set of circumstances..."
QA Manager – Class II device Manufacturer,

,
“…ComplianceAcuity promised to ensure we would obtain our 510K approval on time. Instead they delivered well ahead of the standard review duration, in fact 30% ahead of the standard FDA timeline, enabling our company to enter our product to market well ahead of schedule....”
QA Manager – Class II device Manufacturer
2016-09-28acuity_admin719
“…ComplianceAcuity promised to ensure we would obtain our 510K approval on time. Instead they delivered well ahead of the standard review duration, in fact 30% ahead of the standard FDA timeline, enabling our company to enter our product to market well ahead of schedule....”
QA Manager – Class II device ManufacturerQA Manager – Class II device Manufacturer
55stars
“…ComplianceAcuity promised to ensure we would obtain our 510K approval on time. Instead they delivered well ahead of the standard review duration, in fact 30% ahead of the standard FDA timeline, enabling our company to enter our product to market well ahead of schedule....”
Sr Process and Quality Manager – Class II device Manufacturer,

,
"...Kevin Randall is the consummate professional who goes above and beyond when the situation warrants. What I appreciated most about his expertise is that he can teach without lording it over you. If you are looking for an external consultant to help with those complex FDA, Health Canada, and/or European Commission regulatory issues, you will be well-served to have a conversation with Kevin Randall..."
Sr Process and Quality Manager – Class II device Manufacturer
2016-09-28acuity_admin719
"...Kevin Randall is the consummate professional who goes above and beyond when the situation warrants. What I appreciated most about his expertise is that he can teach without lording it over you. If you are looking for an external consultant to help with those complex FDA, Health Canada, and/or European Commission regulatory issues, you will be well-served to have a conversation with Kevin Randall..."
Sr Process and Quality Manager – Class II device ManufacturerSr Process and Quality Manager – Class II device Manufacturer
55stars
"...Kevin Randall is the consummate professional who goes above and beyond when the situation warrants. What I appreciated most about his expertise is that he can teach without lording it over you. If you are looking for an external consultant to help with those complex FDA, Health Canada, and/or European Commission regulatory issues, you will be well-served to have a conversation with Kevin Randall..."
Director of Operations – Class II and III device Manufacturer,

,
“…Thanks again for all your help! I am amazed how quickly you have gotten these submissions through the process!”
Director of Operations – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…Thanks again for all your help! I am amazed how quickly you have gotten these submissions through the process!”
Director of Operations – Class II and III device ManufacturerDirector of Operations – Class II and III device Manufacturer
55stars
“…Thanks again for all your help! I am amazed how quickly you have gotten these submissions through the process!”
QA Manager – Class II device Manufacturer,

,
“…ComplianceAcuity’s capabilities in managing the FDA review process are strong. Kevin would keep us updated at all times during his interaction with the FDA as our representative. He would ensure that we completely understood what we were up against. If we had an issue with some of the FDA requests, ComplianceAcuity would go to bat to ensure FDA understood our request to dispute certain requests and vice versa (helping us understand the FDA requirements)...”
QA Manager – Class II device Manufacturer
2016-09-28acuity_admin719
“…ComplianceAcuity’s capabilities in managing the FDA review process are strong. Kevin would keep us updated at all times during his interaction with the FDA as our representative. He would ensure that we completely understood what we were up against. If we had an issue with some of the FDA requests, ComplianceAcuity would go to bat to ensure FDA understood our request to dispute certain requests and vice versa (helping us understand the FDA requirements)...”
QA Manager – Class II device ManufacturerQA Manager – Class II device Manufacturer
55stars
“…ComplianceAcuity’s capabilities in managing the FDA review process are strong. Kevin would keep us updated at all times during his interaction with the FDA as our representative. He would ensure that we completely understood what we were up against. If we had an issue with some of the FDA requests, ComplianceAcuity would go to bat to ensure FDA understood our request to dispute certain requests and vice versa (helping us understand the FDA requirements)...”
QA Manager – Class II device Manufacturer,

,
“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional...”
QA Manager – Class II device Manufacturer
2016-09-28acuity_admin719
“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional...”
QA Manager – Class II device ManufacturerQA Manager – Class II device Manufacturer
55stars
“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional...”
Director of Operations – Class II and III device Manufacturer,

,
“…Regarding the 510k submission that you conducted for [us], we were very satisfied with the results…You worked in concert with our QA department to keep the process on task and meet our project deadlines. I was impressed by your work with the FDA personnel when the document was submitted. You were able to get it submitted and reviewed promptly. When FDA had a request for additional documentation, you were able to provide a template for our Patient Instruction booklet that allowed us to complete the content efficiently...”
Director of Operations – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…Regarding the 510k submission that you conducted for [us], we were very satisfied with the results…You worked in concert with our QA department to keep the process on task and meet our project deadlines. I was impressed by your work with the FDA personnel when the document was submitted. You were able to get it submitted and reviewed promptly. When FDA had a request for additional documentation, you were able to provide a template for our Patient Instruction booklet that allowed us to complete the content efficiently...”
Director of Operations – Class II and III device ManufacturerDirector of Operations – Class II and III device Manufacturer
55stars
“…Regarding the 510k submission that you conducted for [us], we were very satisfied with the results…You worked in concert with our QA department to keep the process on task and meet our project deadlines. I was impressed by your work with the FDA personnel when the document was submitted. You were able to get it submitted and reviewed promptly. When FDA had a request for additional documentation, you were able to provide a template for our Patient Instruction booklet that allowed us to complete the content efficiently...”
QA Manager – Class II and III device Manufacturer,

,
“…As QA Manager I have had several opportunities to work with ComplianceAcuity, specifically, Kevin Randall and 510K submissions. Kevin has the knowledge and experience to provide excellent regulatory guidance. His knowledge of FDA regulations enabled Kevin to write, submit and receive approval for our 510k from the FDA promptly and without issue. Kevin has also provided regulatory guidance regarding import to foreign countries, guidance in shipping into Canada and has done ISO/FDA audits for our company. His knowledge and attention to detail exceeded my expectations. I look forward to working with Kevin on future projects...”
QA Manager – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…As QA Manager I have had several opportunities to work with ComplianceAcuity, specifically, Kevin Randall and 510K submissions. Kevin has the knowledge and experience to provide excellent regulatory guidance. His knowledge of FDA regulations enabled Kevin to write, submit and receive approval for our 510k from the FDA promptly and without issue. Kevin has also provided regulatory guidance regarding import to foreign countries, guidance in shipping into Canada and has done ISO/FDA audits for our company. His knowledge and attention to detail exceeded my expectations. I look forward to working with Kevin on future projects...”
QA Manager – Class II and III device ManufacturerQA Manager – Class II and III device Manufacturer
55stars
“…As QA Manager I have had several opportunities to work with ComplianceAcuity, specifically, Kevin Randall and 510K submissions. Kevin has the knowledge and experience to provide excellent regulatory guidance. His knowledge of FDA regulations enabled Kevin to write, submit and receive approval for our 510k from the FDA promptly and without issue. Kevin has also provided regulatory guidance regarding import to foreign countries, guidance in shipping into Canada and has done ISO/FDA audits for our company. His knowledge and attention to detail exceeded my expectations. I look forward to working with Kevin on future projects...”
Director of Operations – Class II and III device Manufacturer,

,
“…You provided a [design input] template that assisted us with the Design History File that was useful to organize our activities. You worked in concert with our QA department to keep the process on task and meet our project deadlines...”
Director of Operations – Class II and III device Manufacturer
2016-09-28acuity_admin719
“…You provided a [design input] template that assisted us with the Design History File that was useful to organize our activities. You worked in concert with our QA department to keep the process on task and meet our project deadlines...”
Director of Operations – Class II and III device ManufacturerDirector of Operations – Class II and III device Manufacturer
55stars
“…You provided a [design input] template that assisted us with the Design History File that was useful to organize our activities. You worked in concert with our QA department to keep the process on task and meet our project deadlines...”
Director of Quality – Class II & III device Manufacturer,

,
“…Kevin responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”
Director of Quality – Class II & III device Manufacturer
2016-09-28acuity_admin719
“…Kevin responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”
Director of Quality – Class II & III device ManufacturerDirector of Quality – Class II & III device Manufacturer
55stars
“…Kevin responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”
VP Regulatory and Scientific Affairs, Class III devices,

,
“…A terrific piece of work, I can see why you have such success with Canadian submissions – Thank You!”
VP Regulatory and Scientific Affairs, Class III devices
2016-09-28acuity_admin719
“…A terrific piece of work, I can see why you have such success with Canadian submissions – Thank You!”
VP Regulatory and Scientific Affairs, Class III devicesVP Regulatory and Scientific Affairs, Class III devices
55stars
“…A terrific piece of work, I can see why you have such success with Canadian submissions – Thank You!”
President & CEO, Class II device Manufacturer,

,

"...You were able to integrate with company staff and work alongside them as if an employee and thus were able to complete the tasks while simultaneously achieve acceptance by internal staff and employees..."

President & CEO, Class II device Manufacturer
2016-09-28acuity_admin719
"...You were able to integrate with company staff and work alongside them as if an employee and thus were able to complete the tasks while simultaneously achieve acceptance by internal staff and employees..."
President & CEO, Class II device ManufacturerPresident & CEO, Class II device Manufacturer
55stars
"...You were able to integrate with company staff and work alongside them as if an employee and thus were able to complete the tasks while simultaneously achieve acceptance by internal staff and employees..."
Director of Operations – Class III device Manufacturer & Distributor,

,
“…We are further along in our business because of ComplianceAcuity’s consulting services. When colleagues ask if I know a good FDA consultant, ComplianceAcuity is the first to come to mind. We will definitely work with ComplianceAcuity again...”
Director of Operations – Class III device Manufacturer & Distributor
2016-09-28acuity_admin719
“…We are further along in our business because of ComplianceAcuity’s consulting services. When colleagues ask if I know a good FDA consultant, ComplianceAcuity is the first to come to mind. We will definitely work with ComplianceAcuity again...”
Director of Operations – Class III device Manufacturer & DistributorDirector of Operations – Class III device Manufacturer & Distributor
55stars
“…We are further along in our business because of ComplianceAcuity’s consulting services. When colleagues ask if I know a good FDA consultant, ComplianceAcuity is the first to come to mind. We will definitely work with ComplianceAcuity again...”
Office Manager – Class II Software Device,

,
"...Thank you Kevin – [The complaint handling training] was extremely helpful for me..."
Office Manager – Class II Software Device
2021-01-01krandallca
"...Thank you Kevin – [The complaint handling training] was extremely helpful for me..."
Office Manager – Class II Software DeviceOffice Manager – Class II Software Device
55stars
"...Thank you Kevin – [The complaint handling training] was extremely helpful for me..."
President – Class II & III device Manufacturer,

,

“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in these areas: FDA quality system compliance, training, and auditing; Supporting the business objectives of a medical device enterprise; and Due diligence assessments related to acquisitions of medical device enterprises. I strongly recommend the services of ComplianceAcuity, and will use them again...”

President – Class II & III device Manufacturer
2021-07-21acuity_admin719
“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in these areas: FDA quality system compliance, training, and auditing; Supporting the business objectives of a medical device enterprise; and Due diligence assessments related to acquisitions of medical device enterprises. I strongly recommend the services of ComplianceAcuity, and will use them again...”
President – Class II & III device ManufacturerPresident – Class II & III device Manufacturer
55stars
“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in these areas: FDA quality system compliance, training, and auditing; Supporting the business objectives of a medical device enterprise; and Due diligence assessments related to acquisitions of medical device enterprises. I strongly recommend the services of ComplianceAcuity, and will use them again...”
Director, Development and Manufacturing Operations – Class II device Manufacturer,

,
"...I would describe your training in design controls to be the foundation of my current understanding of agency requirements. You were the first company I worked with to take the time to dredge through the details. Something I badly needed to complete the picture of developing a design control, and product launch framework."
Director, Development and Manufacturing Operations – Class II device Manufacturer
2021-07-21acuity_admin719
"...I would describe your training in design controls to be the foundation of my current understanding of agency requirements. You were the first company I worked with to take the time to dredge through the details. Something I badly needed to complete the picture of developing a design control, and product launch framework."
Director, Development and Manufacturing Operations – Class II device ManufacturerDirector, Development and Manufacturing Operations – Class II device Manufacturer
45stars
"...I would describe your training in design controls to be the foundation of my current understanding of agency requirements. You were the first company I worked with to take the time to dredge through the details. Something I badly needed to complete the picture of developing a design control, and product launch framework."
GMP Training Attendee,

,
“…I really appreciated how examples of the Preamble were often cited, as the FDA also cited the importance of them in their training…”
GMP Training Attendee
2021-07-21acuity_admin719
“…I really appreciated how examples of the Preamble were often cited, as the FDA also cited the importance of them in their training…”
GMP Training AttendeeGMP Training Attendee
55stars
“…I really appreciated how examples of the Preamble were often cited, as the FDA also cited the importance of them in their training…”
GMP Training Attendee,

,
“…Kevin was very engaging throughout the presentations. His content was well presented, and the slides coincided with the presentation. Overall, I learned a lot from this program…”
GMP Training Attendee
2021-07-21acuity_admin719
“…Kevin was very engaging throughout the presentations. His content was well presented, and the slides coincided with the presentation. Overall, I learned a lot from this program…”
GMP Training AttendeeGMP Training Attendee
55stars
“…Kevin was very engaging throughout the presentations. His content was well presented, and the slides coincided with the presentation. Overall, I learned a lot from this program…”
GMP Training Attendee,

,
“…Kevin – Loved your passion and thorough understanding. Good presentation – clear and articulate…”
GMP Training Attendee
2021-07-21acuity_admin719
“…Kevin – Loved your passion and thorough understanding. Good presentation – clear and articulate…”
GMP Training AttendeeGMP Training Attendee
55stars
“…Kevin – Loved your passion and thorough understanding. Good presentation – clear and articulate…”
GMP Training Attendee,

,
“…Kevin's interaction and communication is always respectful and clear. He has demonstrated an ability to explain concepts in a manner which is applicable to the audience…”
GMP Training Attendee
2021-07-21acuity_admin719
“…Kevin's interaction and communication is always respectful and clear. He has demonstrated an ability to explain concepts in a manner which is applicable to the audience…”
GMP Training AttendeeGMP Training Attendee
55stars
“…Kevin's interaction and communication is always respectful and clear. He has demonstrated an ability to explain concepts in a manner which is applicable to the audience…”
GMP Training Attendee,

,
“…Kevin’s pace and speaking style brought life to the regulations…”
GMP Training Attendee
2021-07-21acuity_admin719
“…Kevin’s pace and speaking style brought life to the regulations…”
GMP Training AttendeeGMP Training Attendee
55stars
“…Kevin’s pace and speaking style brought life to the regulations…”
GMP Training Attendee,

,
“…Training was very good for the whole team, and being able to be present and attend to specific requests was most valuable. Working through all the issues identified, Kevin was able to propose and guide through many solutions…”
GMP Training Attendee
2021-07-21acuity_admin719
“…Training was very good for the whole team, and being able to be present and attend to specific requests was most valuable. Working through all the issues identified, Kevin was able to propose and guide through many solutions…”
GMP Training AttendeeGMP Training Attendee
55stars
“…Training was very good for the whole team, and being able to be present and attend to specific requests was most valuable. Working through all the issues identified, Kevin was able to propose and guide through many solutions…”
GMP Training Attendee,

,
“…Kevin Randall did an excellent job elaborating on the slides, stating not only the FDA regulations, but also the real world expectations for the regulations…”
GMP Training Attendee
2021-07-21acuity_admin719
“…Kevin Randall did an excellent job elaborating on the slides, stating not only the FDA regulations, but also the real world expectations for the regulations…”
GMP Training AttendeeGMP Training Attendee
55stars
“…Kevin Randall did an excellent job elaborating on the slides, stating not only the FDA regulations, but also the real world expectations for the regulations…”

Testimonials

“…The [EU MDR] gap assessment was great! It really helped me methodically work through each item to ensure that everything got done correctly and timely. The amount of work and detail you put into it certainly made my life much easier...”

Regulatory Compliance Manager

“…The [EU MDR] gap assessment was great! It really helped me methodically work through each item to ensure that everything got done correctly and timely. The amount of work and detail you put into it certainly made my life much easier...”

“…The [EU MDR] gap assessment was great! It really helped me methodically work through each item to ensure that everything got done correctly and timely. The amount of work and detail you put into it certainly made my life much easier...”

Regulatory Compliance Manager

Manager, Regulatory Compliance

"...Good news, I passed the [EU MDR] “Audit” for my technical files...thanks for your work on this..."

President

"...Good news, I passed the [EU MDR] “Audit” for my technical files...thanks for your work on this..."

"...Good news, I passed the [EU MDR] “Audit” for my technical files...thanks for your work on this..."

"...This [EU MDR Gap assessment] is an amazing work..."

President

"...This [EU MDR Gap assessment] is an amazing work..."

"...This [EU MDR Gap assessment] is an amazing work..."

"...Wow, your [EU MDR Technical Documentation] work is yet epic again. Much appreciated and that completes my file...Thanks and whew!"

President

"...Wow, your [EU MDR Technical Documentation] work is yet epic again. Much appreciated and that completes my file...Thanks and whew!"

"...Wow, your [EU MDR Technical Documentation] work is yet epic again. Much appreciated and that completes my file...Thanks and whew!"

"...I was very impressed with the EU MDR Clinical Evaluation Report, by the way. Great job..."

President

"...I was very impressed with the EU MDR Clinical Evaluation Report, by the way. Great job..."

"...I was very impressed with the EU MDR Clinical Evaluation Report, by the way. Great job..."

"...We really appreciate your work. Looking forward to an EU MDR invoice. As always, thank you for everything..."

Chief Operating Officer

"...We really appreciate your work. Looking forward to an EU MDR invoice. As always, thank you for everything..."

"...We really appreciate your work. Looking forward to an EU MDR invoice. As always, thank you for everything..."

"...Kevin Randall with Compliance Acuity, has been used for the last 3 years of quarterly internal audits. He is reasonable and easy to work with; we plan to continue to use him..."

Precision Device Manufacturer

"...Kevin Randall with Compliance Acuity, has been used for the last 3 years of quarterly internal audits. He is reasonable and easy to work with; we plan to continue to use him..."

"...Kevin Randall with Compliance Acuity, has been used for the last 3 years of quarterly internal audits. He is reasonable and easy to work with; we plan to continue to use him..."

“…The EU MDR SOPs were great and much appreciated. With all the labeling work that I had to do, it would have been very easy for me to just overlook the SOPs or to make them so generic that they wouldn’t be useful....”

Regulatory Compliance Manager

“…The EU MDR SOPs were great and much appreciated. With all the labeling work that I had to do, it would have been very easy for me to just overlook the SOPs or to make them so generic that they wouldn’t be useful....”

“…The EU MDR SOPs were great and much appreciated. With all the labeling work that I had to do, it would have been very easy for me to just overlook the SOPs or to make them so generic that they wouldn’t be useful....”

"...Thanks! This [EU MDR Clinical Evaluation Plan] looks very good..."

President, Chief Engineer – Software Device

"...Thanks! This [EU MDR Clinical Evaluation Plan] looks very good..."

"...Thanks! This [EU MDR Clinical Evaluation Plan] looks very good..."

“…The [EU MDR] importer/distributor assistance was perfect. There were lots of little details that we wouldn’t have grasped without your help. I know that [operations] especially appreciated it....”

Manager, Regulatory Compliance

“…The [EU MDR] importer/distributor assistance was perfect. There were lots of little details that we wouldn’t have grasped without your help. I know that [operations] especially appreciated it....”

“…The [EU MDR] importer/distributor assistance was perfect. There were lots of little details that we wouldn’t have grasped without your help. I know that [operations] especially appreciated it....”

"...Providing not only the answer, but the reasoning used by regulatory agencies was instrumental not only to our device approval, but to managing the product as a whole..."

COO – Class II device Manufacturer

"...Providing not only the answer, but the reasoning used by regulatory agencies was instrumental not only to our device approval, but to managing the product as a whole..."

"...Providing not only the answer, but the reasoning used by regulatory agencies was instrumental not only to our device approval, but to managing the product as a whole..."

GMP Training Attendee

"...You were able to help me manage the QA and Regulatory functions prior to hiring our own staff. This worked very well. You interfaced well with our engineering staff in addressing our most important Quality Management System issues..."

President and CEO, Class II device Manufacturer

"...You were able to help me manage the QA and Regulatory functions prior to hiring our own staff. This worked very well. You interfaced well with our engineering staff in addressing our most important Quality Management System issues..."

"...You were able to help me manage the QA and Regulatory functions prior to hiring our own staff. This worked very well. You interfaced well with our engineering staff in addressing our most important Quality Management System issues..."

“...I will continue to use ComplianceAcuity for our regulatory and quality needs. We have had successful outcomes each time we have used ComplianceAcuity...”

Director, Regulatory Affairs and Quality Assurance, Class II devices

“...I will continue to use ComplianceAcuity for our regulatory and quality needs. We have had successful outcomes each time we have used ComplianceAcuity...”

“...I will continue to use ComplianceAcuity for our regulatory and quality needs. We have had successful outcomes each time we have used ComplianceAcuity...”

Director, Regulatory Affairs and Quality Assurance

Director of Development and Manufacturing Operations – Class II device Manufacturer

"...Highly professional and very detail oriented...Of all the suppliers I have used over the years, ComplianceAcuity earned my highest recommendation..."

COO, Class II device Manufacturer

"...Highly professional and very detail oriented...Of all the suppliers I have used over the years, ComplianceAcuity earned my highest recommendation..."

"...Highly professional and very detail oriented...Of all the suppliers I have used over the years, ComplianceAcuity earned my highest recommendation..."

"...Your services were customized to the specific needs and constraints of our company instead of providing a canned process that did not fit our business model or intended QMS...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS..."

President & CEO, Class II device Manufacturer

"...Your services were customized to the specific needs and constraints of our company instead of providing a canned process that did not fit our business model or intended QMS...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS..."

"...Your services were customized to the specific needs and constraints of our company instead of providing a canned process that did not fit our business model or intended QMS...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS..."

Director, Regulatory Affairs & Quality Assurance, Class II device Manufacturer

“…Well, [Kevin Randall] is the word smith master. His knowledge of QS regs, principles and processes is exceptional and is able to promptly provide solutions...”