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“Mismatched design controls can feel like driving through two feet of mud. You will eventually get to your destination, but it will take a lot more time and effort than it really should. ” In this episode of the <a target="_blank" href="https://naveenagarwalphd.substack.com/podcast">Let's Talk Risk Podcast</a>, Naveen Agarwal and Aaron Joseph discuss the ongoing challenges of design controls in medical devices, particula…

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “Mismatched design controls can feel like driving through two feet of mud. You will eventually get to your destination, but it will take a lot more time and effort than it really should. ” In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Aaron Joseph discuss the ongoing challenges of design controls in medical devices, particula…

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“Mismatched design controls can feel like driving through two feet of mud. You will eventually get to your destination, but it will take a lot more time and effort than it really should. ” In this episode of the <a href="https://naveenagarwalphd.substack.com/podcast" rel="noopener noreferrer">Let's Talk Risk Podcast</a>, Naveen Agarwal and Aaron Joseph discuss the ongoing challenges of design controls in medical devices, particula…

LTR 86: Managing Post-Market Design Changes

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 86: Managing Post-Market Design Changes

LTR 86: Managing Post-Market Design Changes

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