“…you are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line.”
<h1 class="entry-title">Group: FDA Submissions</h1>
– QA Manager – Class II device Manufacturer
“…ComplianceAcuity ensured that our best interests were always priority #1…”
– 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 device Manufacturer
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions…”
– 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 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!”
– President & Founder – Virtual Manufacturer of Class II devices
“…Kevin’s work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way…”