MDR submission for your Medical Device - How to climb Mount Regulatory? General Principles, Challenges & Pitfalls

Every medical device manufacturer must have a quality management system in place that outlines, for example, responsibilities and requirements for risk management, product development and performance studies, market surveillance, and corrective and preventive action management (CAPA).

In this webinar, we'll look together at the challenges manufacturers face and the biggest sources of mistakes when transitioning to the MDR.

Topics include:

• Classification under the Medical Device Regulation
• Structure of technical documentation compared to the MDD
• Correct labeling
• Validation of stability data
• Risk management
• Post-market surveillance

Who should attend?

The event is aimed at all medical device manufacturers who are in the process of adapting their documentation to the Medical Device Regulation 2017/745 (MDR).