Compliance and Regulatory Affairs

Achieving product launch goals and maintaining market tenure require:

business plan that’s intelligently synchronized with proven regulatory strategy; and
experienced management of a robust array of premarket and postmarket regulatory obligations.

Click an item below to see proven compliance and regulatory solutions from ComplianceAcuity that will help you meet your business goals:

FDA / Third-Party Audit Support

FDA 483, Warning Letters, Other Agency Citations

Liaison with Regulatory Agencies

Global Premarket Submissions

U.S. Agent

Recalls and Safety Alerts

Ad/Promo Regulation

U.S. Import/Export

FDA Establishment Registration / Device Listings

Adverse Event Reporting

Testimonials

"...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..."

“…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

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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...”
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...”

“...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...”

“...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...”

"...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

|
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..."

"...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!"

"...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..."

"...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..."

“…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

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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…”
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…”

“…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...”
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...”

“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional...”
, QA Manager – Class II device Manufacturer

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2016-09-28acuity_admin719
“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional...”
55stars
“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional...”

"...[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 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....”
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....”

“…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...”
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...”

"...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

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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..."
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..."

More Testimonials

Call Us Now +1 303.828.0844

Email Us info@complianceacuity.com

Our Company Ridgway, CO 81432, USA

Compliance and Regulatory Affairs

Testimonials

"...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..."

“...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...”

"...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..."

"...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!"

"...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..."

"...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..."

“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional...”

“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional...”

“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional...”

“…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....”

“…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...”