“…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 […]
<h1 class="entry-title">Group: FDA Submissions</h1>
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 finished submission product (content and hard copy appearance) was very professional…”
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 […]
Director of Operations – Class II and III device Manufacturer
“…Thanks again for all your help! I am amazed how quickly you have gotten these submissions through the process!”
Sr Process and Quality Manager – Class II device Manufacturer
“…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 […]
QA Manager – Class II device Manufacturer
“…ComplianceAcuity promised to ensure we would obtain our 510K approval on time. Instead they delivered well ahead of the standard review duration, in fact 30% ahead of the standard FDA timeline, enabling our company to enter our product to market well ahead of schedule….”
President & CEO, Class II device Manufacturer
“…The most significant contribution [by ComplianceAcuity] was managing the interface with the FDA to obtain the clearance with a challenging set of circumstances…”
Director of Operations – Class II and III device Manufacturer
“…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 […]
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 […]