LTR 64: Opportunities and challenges to leverage PCCP for speed to market

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LTR 64: Opportunities and challenges to leverage PCCP for speed to market

Deep insights from a conversation with Yu Zhao.

Naveen Agarwal, Ph.D.

Aug 30, 2024

∙ Paid

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…

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Let's Talk Risk! with Dr. Naveen Agarwal

Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together!

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