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 Ada Health, we will host a third MDR deep dive and workshop Meetup on clinical evaluation and usability testing. We will form informal working groups interested to discuss the topic. Attendees will benefit from the group's shared knowledge and experience. This event will be especially valuable for quality managers, product owners, clinical research leads, product designers, and UX researchers.

Please register at the Eventbrite link below before August 15. Note: confirmation of attendance on the Meetup page alone is NOT sufficient.

https://www.eventbrite.com/e/medical-device-regulation-clinical-evaluation-and-usability-testing-tickets-67755194611

AGENDA

19:00 - Intro
Welcome and intro to the concept of a working group
Moderators: Dr. med. Tamara Radakovic (Vivy GmbH) and Jared Cardon (Ada Health GmbH)

19:15 - Working group session
Group 1 - Clinical evaluation
Moderator: Jared Cardon (Ada Health GmbH)
Group 2 - How to do usability tests for a medical product? (related to IEC 62366)
Moderator: Anne Schmitt (smartHelios GmbH)

20:30 - Wrap-up

20:40 - 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.

Come and join our Meetup at the Ada Health Offices!

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More about our friends at Ada Health:

Ada is a global health company founded by doctors, scientists, and industry pioneers to create new possibilities for personal health. Ada’s core system connects medical knowledge with intelligent technology to help all people actively manage their health and medical professionals to deliver effective care. Ada is proud to collaborate with leading health systems and global non-profit organizations to carry out this vision. The #1 medical app for 130 countries, 12 million assessments have been completed since its global launch in 2016.
To learn more, visit www.ada.com.

Tamara Radakovic, MD

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Medical Device Regulation - Clinical Evaluation and Usability Testing

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Digital Health - Next Level

Medical Device Regulation - Clinical Evaluation and Usability Testing

Digital Health - Next Level

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