About ComplianceAcuity^®

Kevin Randall is Principal Consultant at ComplianceAcuity. Be sure to visit his LinkedIn page.

Since entering the profession in 1995, Kevin has continuously contributed to the business goals of medical device companies ranging from small start-ups to large international enterprises.

20+ years building sustainable quality systems and compliance operations.
Distinguished mix of hands-on technical skills and astute management used to devise and implement intelligent strategic plans yielding superior outcomes.
Acclaimed quality systems instructor.
Outstanding aptitude for reforming ineffective regulated operations to achieve gold-standard compliance and output in quality systems and regulatory affairs. Track record of delivering creative and sensible solutions assuring customer needs are met while promoting business growth and profitability. Client feedback confirms that Kevin excels by combining intelligent business planning with proven regulatory and quality system strategy.
Kevin holds two science degrees, has authored articles, taught at local and national conferences, is an ASQ Certified Quality Auditor, and holds RAPS Regulatory Affairs Certifications (RAC) for the U.S., Europe, and Canada.
Supported where needed by an elite team of globally-certified regulatory, clinical, and quality system professionals whose proven commitment and credentials ensure that each new client realizes the same value reflected in our client testimonials.

Accomplishments

Here’s what our customers said about the results obtained with ComplianceAcuity on the team:

Highly customized systems that meet your business needs
Proven expertise and support to expand your markets and products
Faster market launches
Global regulatory expertise to meet your worldwide business goals
Complex projects made manageable
Realistic game plans and tactics
Effective resolution of longstanding compliance problems
Diplomatic problem-solving instead of forced solutions
Harmonization of conflicting parties in your organization
Your best interests are always the first priority
Logical, well-thought out style that is easy to work with

Complex issues explained in an easy to understand way
Diligent and rigorous processing of assignments
Timely responsiveness
Routine communication that facilitates your management decisions
Schedules adjusted to address “emergency” issues
Personal, patient approach
Careful attention to your questions, followed by clear, reliable answers
Strategic counsel that adds value to your business
Business relationships based on a high level of integrity
Experienced, tactful interface with your personnel

Testimonials

“…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 ,

|
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...”

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

|
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..."

"...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 ,

|
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..."

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

|
COO, Class II devices
2001-01-13acuity_admin719
“...Of all the suppliers I have used over the years ComplianceAcuity earned my highest recommendation...”
COO, Class II devicesCOO, Class II devices
55stars
“...Of all the suppliers I have used over the years ComplianceAcuity earned my highest recommendation...”

“…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 ,

|
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...”

"...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 ,

|
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..."

“…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 ,

|
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...”

“…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 ,

|
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…“

“…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 ,

|
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...”

"...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 ,

|
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."

“…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 ,

|
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…”

“…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 ,

|
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....”

“...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 ,

|
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...”

“...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 ,

|
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...”

“…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 ,

|
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…”

“…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 ,

|
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…”

“…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 ,

|
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…”

“…Kevin’s pace and speaking style brought life to the regulations…”
GMP Training Attendee ,

|
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…”

“…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 ,

|
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…”

“…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 ,

|
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…”

“…Kevin – Loved your passion and thorough understanding. Good presentation – clear and articulate…”
GMP Training Attendee ,

|
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…”

“…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 ,

|
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…”

"...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 ,

|
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..."

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

|
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..."

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

|
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!"

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

|
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..."

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

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

“…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 ,

|

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...”

"...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 ,

|

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..."

"...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 ,

|
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..."

More Testimonials

Call Us Now +1 303.828.0844

Email Us [email protected]

Our Company Ridgway, CO 81432, USA

About ComplianceAcuity®

Accomplishments

Testimonials

CEO – Class II device Manufacturer

"...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..."

"...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..."

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

COO, Class II devices

“...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...”

Customer Service Supervisor – Class II & III device Manufacturer

Director of Development and Manufacturing Operations – Class II device Manufacturer

Director of Operations – Class II and III device Manufacturer

Director of Operations – Class III device Manufacturer & Distributor

Director of Operations – Class III device Manufacturer & Distributor

Director, Development and Manufacturing Operations – Class II device Manufacturer

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

Director, Regulatory Affairs & Quality Assurance, Class II devices

Director, Regulatory Affairs and Quality Assurance

“...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...”

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

“…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 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'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 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 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

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

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

“…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

“…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…”

“…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…”

“…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

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

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

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

GMP Training Attendee

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

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