“…We were very pleased with Kevin’s work. He was very knowledgeable regarding the industry Standards and Regulations. He was provided copies of our company’s procedures prior to the scheduled audit and had a good understanding of them in order to perform the audit of our systems and processes. His reports were clear and precise and […]
<h1 class="entry-title">Group: General</h1>
Director of Operations – Class II and III device Manufacturer
“…I have found that you have provided valuable information and guidance during our relationship over the years. You have responded in a timely manner when we need an opinion on regulatory issues and seem to possess a vast knowledge of the Quality System Regulations. Your ability to provide the FDA perspective on various aspects regarding […]
Sr. QA Manager, Design & Development
“…Kevin provided positive critique of our Design Control process that has put us in a better compliance footing with external audits going forward. His foundation-building in this arena has helped the management teams become well prepared and will result in fewer compliance issues…”
Director of Operations – Class III device Manufacturer & Distributor
“…ComplianceAcuity’s audit approach was thorough, yet personable, professional, pragmatic and supremely constructive when compared to prior outsourced audits. ComplianceAcuity’s audit findings were educational and informative thereby enabling us to focus our resources in the right places…”
Director of Operations – Class III device Manufacturer & Distributor
“…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 […]
Sr. QA Manager, Design & Development
“…ComplianceAcuity built a foundation for Design Controls that carry forward to the current time which has made the whole design control effort more sustainable with current head count level. This was chiefly done by mapping the requirements to the final product testing effort…”
Sr. Quality Engineer – Class II & III device Manufacturer
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with…”
QA Manager – Class II device Manufacturer
“…ComplianceAcuity ensured that our best interests were always priority #1…”
Business Development – Class II Device Virtual Manufacturer
“…I appreciate all the assistance you have provided and look forward to working with you in the future…”
QA Director and VP of R&D – Virtual Manufacturer of Class III implantable devices
“…We were quite impressed with your abilities…”