Speaking Of Medtech, Ep. 3: FDA Quality System Regulation Harmonization

In this episode of Speaking Of Medtech we talk about arguably one of the biggest regulatory changes to come down the pike in decades: the ongoing harmonization of the US FDA’s QSR, which is going to broadly change the way the agency handles medical device quality oversight. Medtech Insight articles addressing topics discussed in this episode: • QSR Author Says FDA – Not Industry – Will Need Most Time To Adapt To New Quality System Reg • QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo • FDA’s Draft QSR: ‘Lucy’ Pulled The Football Away. Again