This is a free preview of a paid episode. To hear more, visit <a href="https://naveenagarwalphd.substack.com?utm_medium=podcast&utm_campaign=CTA_7">naveenagarwalphd.substack.com</a> Summary“The Digital Health Center of Excellence was hit pretty heavy, and also AI researchers at OSEL. I am not too worried about PCCP but the impact could be on how quickly FDA can finalize the other draft guidance with larger scope applied to all medical devices.” In this episode of the <a target="_blank" href="https://naveenagarwalphd.substack.com/podcast">Let's Talk Risk Podcast</a>, Naveen Agarwal and Yu Zhao discuss the P…

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “The Digital Health Center of Excellence was hit pretty heavy, and also AI researchers at OSEL. I am not too worried about PCCP but the impact could be on how quickly FDA can finalize the other draft guidance with larger scope applied to all medical devices.” In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Yu Zhao discuss the P…

This is a free preview of a paid episode. To hear more, visit <a href="https://naveenagarwalphd.substack.com?utm_medium=podcast&amp;utm_campaign=CTA_7" rel="noopener noreferrer">naveenagarwalphd.substack.com</a> Summary“The Digital Health Center of Excellence was hit pretty heavy, and also AI researchers at OSEL. I am not too worried about PCCP but the impact could be on how quickly FDA can finalize the other draft guidance with larger scope applied to all medical devices.” In this episode of the <a href="https://naveenagarwalphd.substack.com/podcast" rel="noopener noreferrer">Let's Talk Risk Podcast</a>, Naveen Agarwal and Yu Zhao discuss the P…

LTR 94: The road ahead for PCCPs and AI/ML amidst chaos at the FDA

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! <a href="https://naveenagarwalphd.substack.com?utm_medium=podcast">naveenagarwalphd.substack.com</a>

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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! naveenagarwalphd.substack.com

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! <a href="https://naveenagarwalphd.substack.com?utm_medium=podcast" rel="noopener noreferrer">naveenagarwalphd.substack.com</a>

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LTR 94: The road ahead for PCCPs and AI/ML amidst chaos at the FDA

LTR 94: The road ahead for PCCPs and AI/ML amidst chaos at the FDA

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