Clearly Solving

the Regulatory

Compliance & GMP Puzzle

Compliance and Regulatory Affairs Quality Management Systems (QMS)

™

Sensible customized solutions for sustainable regulatory affairs and quality systems in the medical device and pharma industry

Quality Management Systems (QMS) Testimonials Compliance and Regulatory Affairs

Wondering how your firm could benefit from involving ComplianceAcuity in your business plan?

Welcome to ComplianceAcuity

ComplianceAcuity provides customized, common-sense solutions to achieve sustainable regulatory affairs and quality systems in the medical device and pharma industry. We excel by pairing intelligent business planning with strategic regulatory and quality systems.

Succeeding in today’s dynamic regulatory environment requires that each medical device or pharma business be statutorily fluent yet practical regarding their compliance/regulatory affairs and quality systems.

More About Us

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

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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...”
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...”

"...[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

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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!"
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!"

"...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

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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..."
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..."

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

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

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

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

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

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1900-01-01krandallca
"...We really appreciate your work. Looking forward to an EU MDR invoice. As always, thank you for everything..."
55stars
"...We really appreciate your work. Looking forward to an EU MDR invoice. As always, thank you for everything..."

“…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

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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....”
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....”

"...Thanks! This [EU MDR Clinical Evaluation Plan] looks very good..."
, President, Chief Engineer - Software Device

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1900-01-21krandallca
"...Thanks! This [EU MDR Clinical Evaluation Plan] looks very good..."
45stars
"...Thanks! This [EU MDR Clinical Evaluation Plan] looks very good..."

"...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

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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..."
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..."

“…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

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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…”
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…”

“...Of all the suppliers I have used over the years ComplianceAcuity earned my highest recommendation...”
, COO, Class II devices

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2001-01-13acuity_admin719
“...Of all the suppliers I have used over the years ComplianceAcuity earned my highest recommendation...”
55stars
“...Of all the suppliers I have used over the years ComplianceAcuity earned my highest recommendation...”

"...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

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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..."
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..."

“...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

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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...”
55stars
“...I will continue to use ComplianceAcuity for our regulatory and quality needs. We have had successful outcomes each time we have used ComplianceAcuity...”

“...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

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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...”
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...”

"...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

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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..."
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..."

"...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

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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..."
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..."

“…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…”
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…”

“…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

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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...”
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...”

“…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

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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…“
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…“

“…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....”
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....”

"...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..."
55stars
"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."

“…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

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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...”
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...”

“…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...”
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...”

“…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...”
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...”

“…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...”
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...”

“…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

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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…”
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…”

“…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...”
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...”

“…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...”
55stars
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with...”

“…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...”
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...”

“…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...”
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...”

“…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...”
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...”

“…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!”
55stars
“…A terrific piece of work, I can see why you have such success with Canadian submissions – Thank You!”

“…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...”
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...”

"...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."
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."

“…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…”
55stars
“…I really appreciated how examples of the Preamble were often cited, as the FDA also cited the importance of them in their training…”

“…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…”
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…”

“…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…”
55stars
“…Kevin – Loved your passion and thorough understanding. Good presentation – clear and articulate…”

“…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…”
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…”

“…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…”
55stars
“…Kevin’s pace and speaking style brought life to the regulations…”

“…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…”
,

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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…”
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…”

“…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…”
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…”

More Testimonials

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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...”

“…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...”

"...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..."

"...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..."

"...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!"

"...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..."

"...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..."

"...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..."

“…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....”

“…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..."

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

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

"...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..."

"...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..."

“...Of all the suppliers I have used over the years ComplianceAcuity earned my highest recommendation...”

“...Of all the suppliers I have used over the years ComplianceAcuity earned my highest recommendation...”

“...Of all the suppliers I have used over the years ComplianceAcuity earned my highest recommendation...”

"...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..."

"...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...”

“...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...”

"...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..."

"...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..."

“…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...”

“…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...”

“…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...”