FDA’s ISO 13485 Transition Plan … What Does it Mean for Your Medtech’s Quality Plan?

LISTEN NOW 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 announced, what it looks like, the differences 21 CFR Part 820 vs....

Tips, Tricks, and Best Practices for Complying with ISO13485:2016

LISTEN NOW 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, maybe you just don’t know what you need to do. You are not alone because a lot of...

What are the regulatory expectations for Software as a Medical Device (SaMD)?

LISTEN NOW 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 companies ensure that their documentation, platform, and systems they...

Implementing Changes to SaMD under new EU MDR

LISTEN NOW 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 from clarifications on qualification and classification changes and action...