EU MDR - Introductions and Overview - Risk Management and the EU MDR
11:05 AM - 11:50 AMMon
Speakers
Vinny Sastri, Ph.D.
President
Winovia, LLC
* Purpose and intent of the new EU MDR * Structure of the EU MDR including Annexes 1 to XVII * Focus on references to risk especially in Annex I (General Safety and Performance Requirements) * Links of Risk Management in the EU MDR to Design and Deveopment, Clinical Evaluation, Software Development, Post Market Surveillance and Quality Management Systems * Links to other standards