Do you work for a digital health startup? Are you even a medical product? Then you might be familiar with the term Medical Device Directive (MDD) and its successor Medical Device Regulation (MDR) that will become active in May 2020. This might sound like a dry topic, but it will have a real impact on the medical device field. We in Vivy have learned a lot by going throughout the whole process ourselves. We want to share our experiences with the health startup community.

We believe that health startups are stronger together and everybody benefits from sharing insights. Together with Berlin healthcare startups, we have initiated a series of events that focus on MDR requirements, where the goal is to bring experts together and engage participants to gain practical insights.

Together with the lovely people at MX Healthcare, we will host a fourth MDR deep dive and workshop Meetup focusing on the software lifecycle of medical devices. This time our moderators will start with sharing their story and insights on becoming a medical product class 2 and after attendees will benefit from the group's shared knowledge and experience. This event will be especially valuable for quality managers, consultants, regulatory and compliance managers, product owners and product designers.

AGENDA

19:00 - Intro
Warm welcome and introduction
Moderators: Dr. Tamara Radakovic (Vivy GmbH) and Dr. Oliver Eidel (MX Healthcare)

19:15 - 19:45
Story: Beware of waterfalls: How we do IEC 62304- compliant software development at MX Healthcare
Moderator: Dr. Oliver Eidel (MX Healthcare)

19:45 - 20.15
Q&A session and open discussion on the topics
Moderator: Dr. Tamara Radakovic (Vivy GmbH)
Participants: Jared Cardon (Ada Health GmbH), Dr. Oliver Eidel (MX Healthcare), Pascal Werner (Consultant)

20:15 - 21:00 Wrap up and get-together

To be best prepared and make the best use of everybody's time, we would love to collect questions from your side before the Meetup! Just send us your questions beforehand via direct message.

Location details:

MX Healthcare GmbH
Friedrichstraße 125
10117 Berlin

Instruction: Walk straight through to the courtyard and enter the white door at the end of it.

Come and join our Meetup at the MX Healthcare (Merantix) Offices!

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More about our friends at MX Healthcare:

MX Healthcare is a spin-off of Merantix which aims to create products based on Machine Learning. Their product, Vara, is a radiology application that makes breast cancer screening more efficient and safe.

Tamara Radakovic, MD

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Medical Device Regulation #4 - Software lifecycle 

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Medical Device Regulation #4 - Software lifecycle

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