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Basics of Regulatory Affairs for Start-ups in Medical Technology

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A joint event from EIT Health Germany, Medidee and BadenCampus Online Seminar Series - Part I

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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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Moderation: Dr. Michael Lüttgen, EIT Health Germany

Presentation: Medidee Services

Language: English

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Agenda Day 1 (Tuesday, 18.05.2021)

09:15: Welcome by the Organizers

09:20: Introduction – Steps to CE Mark for Medical Devices (Medidee)

  • MDR / IVDR
  • Medical device classification – conformity assessment
  • General safety and performance requirements (GSPR)
  • State of the art concept – principle of presumption of conformity
  • Role of Notified Bodies and working with Notified Bodies
  • Status update – implementation of MDR / IVDR

10:30: V&V and Technical Documentation (Medidee)

  • Risk management & usability engineering
  • Setting up a design & development process
  • From user requirements to design validation
  • Design verification and pre-clinical validation
  • Technical documentation as evidence for compliance

12:00: Open Q&A (all speakers) - End of Day 1

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Joint Lunch Break (feel free to stay for a chat and exchange your thoughts)

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Agenda Day 2 (Wednesday, 19.05.2021)

09:15: Welcome by the Organizers

09:20: Clinical Evidence (Medidee)

  • Clinical data, clinical evaluation and equivalence discussion
  • Post market surveillance & post market clinical follow-up

10:30: US Market Access for Medical Devices (Medidee)

  • Regulatory framework
  • Classification: 510(k), De Novo, HDE, PMA
  • FDA medical devices databases
  • Pre-submission programme
  • Differences between US and EU regulatory frameworks

11:40: Start-up and Regulatory – avoiding pitfalls (Medidee)

  • Milestones of a medical device innovation project, a different view

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.

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