Benefit-Risk Requirements in EU-MDR

Benefit-Risk Analysis is an important concept for risk management of medical devices, though it is difficult and challenging to do in practice. This is a key requirement in the EU MDR recently put into effect and is very important to understand in order to properly evaluate the safety of medical devices. In this video, we will review some of the key regulatory requirements in EU-MDR and discuss an overall framework of key factors to do a benefit-risk analysis. 👉Subscribe to the Let's Talk Risk! newsletter https://naveenagarwalphd.substack.com/ 👉Connect on LinkedIn   / naveenagarwal