“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in these areas: FDA quality system compliance, training, and auditing; Supporting the business objectives of a medical device enterprise; and Due diligence assessments related to acquisitions of medical device enterprises. I strongly […]
<h1 class="entry-title">Group: General</h1>
Office Manager – Class II Software Device
“…Thank you Kevin – [The complaint handling training] was extremely helpful for me…”
Director of Operations – Class III device Manufacturer & Distributor
“…We are further along in our business because of ComplianceAcuity’s consulting services. When colleagues ask if I know a good FDA consultant, ComplianceAcuity is the first to come to mind. We will definitely work with ComplianceAcuity again…”
President & CEO, Class II device Manufacturer
“…You were able to integrate with company staff and work alongside them as if an employee and thus were able to complete the tasks while simultaneously achieve acceptance by internal staff and employees…”
VP Regulatory and Scientific Affairs, Class III devices
“…A terrific piece of work, I can see why you have such success with Canadian submissions – Thank You!”
Director of Quality – Class II & III device Manufacturer
“…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 […]
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 […]