“…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…”
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. […]
Regulatory Compliance Manager
“…[the EU MDR reviewer] has completed their review of the technical documentation and didn’t request any revisions! Sounds like it shouldn’t be long before we get our approval to ship to the EU! Thanks Kevin for the excellent work! [The EU MDR reviewer] originally told me they usually have 2-3 rounds of revisions, but we […]
Regulatory Compliance Manager
“…The [EU MDR] gap assessment was great! It really helped me methodically work through each item to ensure that everything got done correctly and timely. The amount of work and detail you put into it certainly made my life much easier…”