In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s recently implemented QMSR. It went into effect on February 2nd and replaced 21 CFR Part 820. The regulation incorporates ISO 

, which is expected to help align medical device regulations globally. In this podcast, we focus on what device manufacturers should be doing now and what can wait for a later time. During this conversation, the following quest...

FDA's Third-Party Review Program

A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.