Exploring the gap between FDA and MDR risk management requirements

The EU MDR has fundamentally reshaped how manufacturers need to think about risk management. In the past, medical device manufacturers with FDA-approved products found that their existing processes essentially met the requirements of the MDD. However, Notified Bodies are now taking a larger and more comprehensive view of risk management in planning, post-market assessment, and the living process of organizational risk control. Join us as we go beyond ISO 14971:2019 and dive into the new expectations because of the EU MDR and other worldwide trends with one of our favorite regulatory experts, Nathan Dowd of med-sherpa. Bring your questions!