MDR submission for your Medical Device - How to climb Mount Regulatory? General Principles, Challenges & Pitfalls
Reister now for the free live webinar "MDR submission for your Medical Device - How to climb Mount Regulatory? General Principles, Challenges & Pitfalls"
Access webinar on-demand (in English)
Access webinar on-demand (in German)
About the webinar
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:
- 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
At the end of the webinar there is going to be a live Q&A Session.
This webinar is presented by Jana Osterritter, Consultant Regulatory Affairs and Quality Management.
Two sessions are offered for this event:
Session in GERMAN, 20.04.23., 11:00-12:00 CET
Session in ENGLISH, 20.04.23., 16:00-17:00 CET
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).
Speaker:
Jana Osterritter, Consultant Regulatory Affairs and Quality Management
As a biomedical engineer, Jana Osterritter has been involved in the development and approval of medical devices for several years. At Eurofins BioPharma Services Consulting Munich GmbH, she advises clients on quality management and technical documentation, but also on general regulatory issues relating to medical devices.
