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Autumn-Update medical.device.forum
ConferenceAutumn 2026, Hamburg (Germany)in-personConference Language: German
The Autumn-Update medical.device.forum is designed for people in charge of quality management, regulatory affairs, risk and product management and offering implementation support for current regulatory requirements for medical devices.
The goal of the conference is to address key issues and challenges in interpreting and implementing the EU medical devices regulation. The presentations will provide you with the latest information on relevant legal acts, harmonized standards, and common specifications.
The forum provides implementation possibilities for medical device manufacturers as well as a platform for professional exchange.
- Current status of the implementation of medical device regulation in Europe and Germany
- Current status of regulation for MDR in medical device industry
- Clinical assessment according to MDR
- Postmarket surveillance
- What will change with the renaming of the notified bodies?
- Digital technical documentation
- MDR audit preparation, successful certification and implementation in the QMS
- Responsible person (Art. 15 MDR / IVDR) and current judgments on medical device law that must be observed
- Impact of the updated version of ISO 14155:2020
- Implementation of the third edition of ISO 14971
- Supplier management according to MDR
- Materials and biological safety based on ISO 10993 in combination with the MDR
- Current regulatory requirements for medical apps
- Manufacturers of medical devices: managing directors, quality managers
- Those responsible from the areas of regulatory affairs, clinical affairs, R&D, project managers, product managers
- Distributors and operators of medical devices
- Official representatives from authorities
- Associations
- Consulting companies in the medical device industry
- Clinical research organizations in the medical device environment
Handwerkskammer Hamburg
Holstenwall 12
20355 Hamburg, Germany For information about the venue, how to get there and hotels near the venue please click here.
If you would like to be notified when the program is released, please click here.