<h1 class="entry-title">Group: FDA Submissions</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 […]

– QA Manager – Class II and III device Manufacturer

“…As QA Manager I have had several opportunities to work with ComplianceAcuity, specifically, Kevin Randall and 510K submissions. Kevin has the knowledge and experience to provide excellent regulatory guidance. His knowledge of FDA regulations enabled Kevin to write, submit and receive approval for our 510k from the FDA promptly and without issue. Kevin has also […]

– Director of Operations – Class II and III device Manufacturer

“…Regarding the 510k submission that you conducted for [us], we were very satisfied with the results…You worked in concert with our QA department to keep the process on task and meet our project deadlines. I was impressed by your work with the FDA personnel when the document was submitted. You were able to get it […]

– QA Manager – Class II device Manufacturer

“…ComplianceAcuity’s capabilities in managing the FDA review process are strong.  Kevin would keep us updated at all times during his interaction with the FDA as our representative. He would ensure that we completely understood what we were up against.  If we had an issue with some of the FDA requests, ComplianceAcuity would go to bat […]