Global Medical Device Podcast powered by Greenlight Guru

Global Medical Device Podcast powered by Greenlight Guru


#389: Pre-determined Change Control Plans

October 31, 2024

In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues discuss FDA's new framework, the Predetermined Change Control Plan (PCCP), designed to streamline change approvals for medical devices. Originally devel