The Event will take place online. As soon as you have registered, you’ll receive the Log-in Details. We recommend to attend both seminar days as the content was created based on a holistic approach. #fromideatomarket

Join us for Part I of the Seminar Series “Market Access and Basics of Regulatory Affairs for Start-ups in Medical Technology” and get an overview of the regulatory landscape and regulatory stakeholders in Medtech, understand the major principles, concepts and processes and learn how to sequence the necessary steps and build awareness of possible pitfalls when bringing a Medtech product to the market. All participants will receive a certificate of attendance.
We invite you to stay tuned for Part II of the Series, which is going to take place in October.

Moderation: Dr. Michael Lüttgen, EIT Health Germany

Presentation: Medidee Services

Agenda Day 1 – 17.06.2020

09:15
Welcome by the Organizers

09:20
Introduction – Steps to CE Mark for Medical Devices
Speaker: Michael Maier
– 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
Speaker: Dr. Linda Ahnen
– 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 – End of Day 1
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Joint Lunch Break (feel free to stay for a chat and exchange your thoughts)

Although we cannot meet in person, we would like you to get delivered directly at your place some good food from a restaurant of your choice*. The vouchers of the amount of 20 € are limited and will be distributed on the first-come-first-serve-basis. Let us know if you’d like to join via the registration form.

*Vouchers can be used here. On the website, you’ll find all the participating restaurants all over Germany. The plattform mainly supports local restaurants. Take the chance, find out who offers pick-up or delivery services and #supportyourlocal!
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Agenda Day 2 – 18.06.2020

09:15
Welcome by the Organizers

09:20
Clinical Evidence
Speaker: Dr. Linda Ahnen
– Clinical data, clinical evaluation and equivalence discussion
– Post market surveillance & post market clinical follow-up

10:30
US Market Access for Medical Devices
Speaker: Dr. William Enns-Bray
– 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
Speaker: Michael Maier
– Milestones of a medical device innovation project, a different view

12:00
Open Q&A, Closing, Outlook

This event is a joint initiative of the organizers EIT Health Germany, Medidee Services and Badencampus.

Click here to register.