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“When the notified body goes back and asks you (the manufacturer) for more information, they aren’t necessarily saying that whatever you have done is wrong.” Clinical evaluation is a major requirement for medical devices under the EU regulation, and notified bodies must determine whether the evidence provided by the manufacturer is scientifically…

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “When the notified body goes back and asks you (the manufacturer) for more information, they aren’t necessarily saying that whatever you have done is wrong.” Clinical evaluation is a major requirement for medical devices under the EU regulation, and notified bodies must determine whether the evidence provided by the manufacturer is scientifically…

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“When the notified body goes back and asks you (the manufacturer) for more information, they aren’t necessarily saying that whatever you have done is wrong.” Clinical evaluation is a major requirement for medical devices under the EU regulation, and notified bodies must determine whether the evidence provided by the manufacturer is scientifically…

LTR 92: Understanding the notified body perspective on clinical evaluation

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>

Technology

Education

How To

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>

Share LTR 92: Understanding the notified body perspective on clinical evaluation

Sign up to save your podcasts

LTR 92: Understanding the notified body perspective on clinical evaluation

LTR 92: Understanding the notified body perspective on clinical evaluation

More shows like Let's Talk Risk! with Dr. Naveen Agarwal

Global News Podcast

DeviceTalks Podcast Network