4th Annual US EU MDR & QMS Implementation Conference

The wide scope of EU MDR compliance continues to drive significant cross-functional changes within medical device companies. As global regulatory professionals await further guidance on clinical trial documentation, technical file templates, and database management, implementation efforts continue to take shape. Presenting specific EU requirements that must be present for the QMS adds added complexity in the EU MDR compliance process. The bandwidth of notified bodies is more limited than ever and the capacity of these organizations to provide clarity has often fallen short. Even after the May 2020 MDR deadline, uncertainties continue to delay the development of clinical trial protocols, manufacturing processes, and proper documentation for product certifications.