In this episode of the Project Medtech Podcast, Rook Founder/President Kyle Rose and Duane Mancini discuss in detail the FDA’s ISO-13485 transition plan, when it was…
When it comes to 13485-2016, are you scrambling to meet requirements? Are you trying to figure out the how, what, or when regarding its timeline? Or,…
This podcast was hosted by Andrew Wu, the Software Consultant of Rook Quality Systems. You will find this podcast helpful for understanding how Rook helps SaMD…
Hosted by Andrew Wu of Rook Quality Systems, this podcast will help you understand changes imposed on SaMD under new EU MDR. SaMD manufacturers will benefit…