When: Thursday, 27.06.2019, 18:30 - 21:00h (Entry 18:15)
Where: Clue Offices, Adalbertstraße 8, 10999 Berlin
What: "Medical Device Regulation - Deep Dive and A Working Session"

After the last meetup, we reached out to other companies to align, learn and work together in this regulatory jungle. We believe that healthcare startups are stronger together and everybody benefits from sharing their insights. Together with the lovely people from Clue, we came to an idea for a Medical Device Regulation Meetup where we would form informal working groups (5-7 people) interested in the same topic. Attendees will benefit from the groups shared knowledge and experience.

Important: We are currently looking for a moderator of a Software Life Cycle working group with a technical background who is willing to share insight and experience with others. Please write to us if you are interested: tamara@vivy.com

The places for this event are limited so please make sure that you cancel your attendance in case you are not able to come.

AGENDA

18.30 - Intro
Welcome and intro to the concept of a working group and forming
Moderators: Dr. med. Tamara Radakovic (Vivy GmbH) and Georgie Denis (Clue GmbH)

18:45 - Working Group Session

Working groups:
Software Life Cycle (related to IEC 62304)
Moderator: Dr. Oliver Eidel (MX Healthcare GmbH)

Risk Management (related to ISO 14971)
Moderator: Dr. med. Maya Fehling (Vivy GmbH)

Usability of a medical product (related to IEC 62366)
Moderator: Pia Simonsen (Clue GmbH)

Standard Operating Procedures - How to? (related to ISO 13485)
Moderator: Dr. med. Tamara Radakovic (Vivy GmbH)

Other
20:30 - Wrap-Up

20:40 - Get-Together

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

Come and join our Meetup at Clue!

Tamara Radakovic, MD

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Medical Device Regulation - Deeper Dive and A Working Session

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Medical Device Regulation - Deeper Dive and A Working Session

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