<h1 class="entry-title">Group: CE Marking</h1>

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 […]

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….”

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….”

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

“…Good news, I passed the [EU MDR] “Audit” for my technical files…thanks for your work on this…”

Manager, Regulatory Compliance

“…the [EU MDR technical documentation] boilerplates were perfect and so much better than what we had previously. They made it very easy for me to “fill in the blanks”, as well as end up with one concise, easy to manage, document instead of the hodgepodge of documents we previously had in our MDD tech files.  […]