Interactive Q&A: Focus on Risk Requirements in EU-MDR - April 16th

In our Interactive Q&A session in April, we focused on Risk Requirements in EU-MDR. We talked about differences in requirements between EU-MDR and ISO 14971:2019 for disclosure of residual risks. We also discussed the current state of harmonization of this International Standard with EU-MDR. Europe has adopted ISO 14971 without any modifications and without any Z Annexes. This is causing a lot of uncertainty about how the two will be harmonized for regulatory purposes. 👉Subscribe to the Let's Talk Risk! newsletter https://naveenagarwalphd.substack.com/ 👉Connect on LinkedIn   / naveenagarwal