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“You can definitely use (GenAI) as your core algorithm, but you need to enforce that it can only do one specific thing or at least a very clarified labeling. ” In this episode of the <a target="_blank" href="https://naveenagarwalphd.substack.com/podcast">Let's Talk Risk Podcast</a>, host Naveen Agarwal engages with Dr. Yujan Shrestha to explore the rapid advancements of AI and ML in the medical device industry. They dis…

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “You can definitely use (GenAI) as your core algorithm, but you need to enforce that it can only do one specific thing or at least a very clarified labeling. ” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal engages with Dr. Yujan Shrestha to explore the rapid advancements of AI and ML in the medical device industry. They dis…

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“You can definitely use (GenAI) as your core algorithm, but you need to enforce that it can only do one specific thing or at least a very clarified labeling. ” In this episode of the <a href="https://naveenagarwalphd.substack.com/podcast" rel="noopener noreferrer">Let's Talk Risk Podcast</a>, host Naveen Agarwal engages with Dr. Yujan Shrestha to explore the rapid advancements of AI and ML in the medical device industry. They dis…

LTR 87: A Strategic Approach to Regulatory Success with GenAI Devices

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 87: A Strategic Approach to Regulatory Success with GenAI Devices

LTR 87: A Strategic Approach to Regulatory Success with GenAI Devices

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