Medical Device Regulation - Curse or blessing?

When: Thursday, 16.05.2019, 19:00 - 21:00h (Entry 18:30)
Where: Vivy-Office, Schützenstr. 18, 10117 Berlin
What: "Medical Device Regulation - Curse or blessing?"

Are you working in a digital health startup? Are you even a medical product? Then you might be familiar with the term Medical Device Directive (MDD) and it's successor Medical Device Regulation (MDR) that will become active in May 2020. This sounds like a dry topic? In fact, it might be a become sweaty if you are a medical CE class I. We had to face this ourselves, talked to various different consultants that had all very different viewpoints, became more insecure, read the ISO standards ourselves and recently absolved a regular audit from the LaGeSo (Landesamt für Gesundheit und Soziales).

We reached out to other companies to align and learn and work together in this regulatory jungle. The uptake was mediocre but what became clear is that there is a lot of uncertainty. We believe, that we healthcare startups are stronger together and everybody benefits (also financially) from sharing their insights. Therefore, we want to share what we struggled with, share insights and explain the importance and purpose of these regulations. You will have . the opportunity to raise your questions to three experts from the regulatory field.

AGENDA

19:00 - Intro
How does Vivy get in shape for the MDR?
Dr. med. Maya Fehling and Tamara Radakovic, MD

19:15 - Insights from the regulatory side
Dr. Matthias Merx, Auditor, LaGeSo
Dr. Michael Berensmann, Medical Apps / Telemedicine, TÜV Rheinland
Astrid Schulze, Quality Management and Regulatory Affairs, Johner Institute

20:00 - Wrap-Up & Panel Discussion

20:30 - Get-Together

To be best prepared, we would love to collect questions from your side before the meetup! Thereby we ensure that the respective experts can prepare and to make the best use of everyone's time. Just send us your question beforehand via direct message. Also follow us on Twitter (https://twitter.com/vivy_health) to ask live questions during the event!

Come and join our meetup at Vivy's office!