EPISODE · Oct 31, 2024 · 29 MIN
LTR 64: Opportunities and challenges to leverage PCCP for speed to market
from Let's Talk Risk! with Dr. Naveen Agarwal · host Naveen Agarwal, Ph.D.
Summary“PCCP is a great tool for your regulatory strategy but it is not for every company or for every change”. PCCP (Predetermined Change Control Plan) is a new regulatory scheme that allows device manufacturers to implement post-market changes without requiring pre-market submission to the FDA. In this episode, Yu Zhao explains how the PCCP tool offer… This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe
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LTR 64: Opportunities and challenges to leverage PCCP for speed to market
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