“…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 […]
<h1 class="entry-title">Group: CE Marking</h1>
Manager, Regulatory Compliance
“…The [EU MDR] importer/distributor assistance was perfect. There were lots of little details that we wouldn’t have grasped without your help. I know that [operations] especially appreciated it….”
President, Chief Engineer – Software Device
“…Thanks! This [EU MDR Clinical Evaluation Plan] looks very good…”
Regulatory Compliance Manager
“…The EU MDR SOPs were great and much appreciated. With all the labeling work that I had to do, it would have been very easy for me to just overlook the SOPs or to make them so generic that they wouldn’t be useful….”
Precision Device Manufacturer
“…Kevin Randall with Compliance Acuity, has been used for the last 3 years of quarterly internal audits. He is reasonable and easy to work with; we plan to continue to use him…”
Chief Operating Officer
“…We really appreciate your work. Looking forward to an EU MDR invoice. As always, thank you for everything…”
President
“…I was very impressed with the EU MDR Clinical Evaluation Report, by the way. Great job…”
President
“…Wow, your [EU MDR Technical Documentation] work is yet epic again. Much appreciated and that completes my file…Thanks and whew!”
President
“…This [EU MDR Gap assessment] is an amazing work…”
President
“…Good news, I passed the [EU MDR] “Audit” for my technical files…thanks for your work on this…”