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A joint event from EIT Health Germany, Medidee and BadenCampus Online Seminar Series - Part I
Do not risk any delays in the course of your developments! Prepare proactively for the MDR, learn from the experts in this seminar by EIT Health and Medidee*.
How can start-ups in Medical Technology ensure future success? By acquiring regulatory know-how as early as possible! Why is regulation so important for medical technology products? Why should regulatory requirements be addressed as early as possible? What is important? Our seminar will answer these and other burning questions. Increasing regulatory requirements currently place great demands on validation for medical technology and medical devices. The Medical Device Regulation (MDR) and the necessary steps until market entry are becoming more and more urgent. Regulatory know-how is necessary and offers advantages as early as the development stage and significantly secures your later success.
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09:15: Welcome by the Organizers
09:20: Introduction – Steps to CE Mark for Medical Devices (Medidee)
10:30: V&V and Technical Documentation (Medidee)
12:00: Open Q&A (all speakers) - End of Day 1
Joint Lunch Break (feel free to stay for a chat and exchange your thoughts)
09:20: Clinical Evidence (Medidee)
10:30: US Market Access for Medical Devices (Medidee)
11:40: Start-up and Regulatory – avoiding pitfalls (Medidee)
12:00: Open Q&A (all speakers), Closing, Outlook
The Seminar is part of a two-part-series. Part II, "Market Access for MedTech Start-ups", is planned for October 5-6.