Exploring the gap between FDA and MDR risk management requirements

March 22, 1 PM ET

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!