The Event will take place online. We recommend to attend both seminar days as the content was created based on a holistic approach.
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)
Welcome by the Organizers
Introduction – Steps to CE Mark for Medical Devices
– 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
V&V and Technical Documentation
– 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
Open Q&A - End of Day 1
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!
Agenda Day 2 (18.06.2020)
Welcome by the Organizers
– Clinical data, clinical evaluation and equivalence discussion
– Post market surveillance & post market clinical follow-up
US Market Access for Medical Devices
– Regulatory framework
– Classification: 510(k), De Novo, HDE, PMA
– FDA medical devices databases
– Pre-submission programme
– Differences between US and EU regulatory frameworks
Start-up and Regulatory – avoiding pitfalls
– Milestones of a medical device innovation project, a different view
Open Q&A, Closing, Outlook