“…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. […]
<h1 class="entry-title">Group: General</h1>
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 […]