Hardware Podcasts

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

Global Medical Device Podcast · 26 Nov 2019 · 36m · Episode 125

What this episode covers

Mike Drues of Vascular Sciences and John Spear of Greenlight Guru discuss the FDA's expansion of the Case for Quality initiative, a pilot program involving the CMMI Institute and MDIC that shifts focus from mere compliance to true product quality. They analyze the benefits for participating companies, such as exemption from routine inspections and expedited PMA supplement reviews, while debating whether the program's inclusion of non-compliant companies constitutes helpful guidance or inappropriate micromanagement. The conversation highlights the tension between regulatory hurdles and the need for continuous improvement in medical device manufacturing.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, MDIC, CMMI Institute, CMMI

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