Discover the regulatory challenges in the field of digital health! Take part in our regulatory awareness workshop on 4th May, at two available slots 10:00 – 11:00 or 14:00 - 15:00 at Health 2.0 Europe in Barcelona.
The regulatory awareness workshop specifically focuses on challenges that arise to European startups and SMEs in the digital health sector with regard to regulatory requirements and emphasizes the importance of its consideration.
By using case studies this workshop will explain:
- when medical software falls under the medical device directive
- how to classify medical device software
- which key regulatory standards are mandatory
- the impact of the new regulation (MDR) on medical device software
The workshop will take 1 hour, incl. a presentation (45 min.) and a Q&A section (15 minutes).
Please note that the workshop will be taking place twice, once in the morning, and again in the afternoon. The format, speaker and content will be the same.
You may join free of charge and:
- get an overview of the regulatory framework for software medical products
- identify your own regulatory challenges
- develop ideas on how to tackle your regulatory challenges and get to know what support you can receive
- interact with other companies to discuss best practices and collaboration possibilities
Our target
- Early-stage startups and SMEs within the eHealth sector.
- headquarters in Europe*,
- Investors in the field of digital health
- Other regulatory experts in the field of digital health
Experts
Oliver Hilgers
Authorized Officer. Medical Software / Active Medical Devices
CE plus GmbH
Agenda
- Introduction to eHealth Hub project
- Regulatory challenges for digital health companies by using case studies:
- when medical software falls under the medical device directive
- how to classify medical device software
- which key regulatory standards are mandatory
- the impact of the new regulation (MDR) on medical device software
- Question and Answers, open discussion
Contact details
If you have any questions please email Nicole Häusler ([email protected]) or Hackbarth Björn ([email protected])
Registration form
The workshop is free, but registration is mandatory.
This high quality training is delivered completely free of charge (except travel expenses to the live session) as it is funded by the European Commission via the eHealth Hub project. The project plans to deliver other 2 regulatory workshops with live events in other European locations. If you cannot attend this edition, join our mailing list to stay tuned for future editions.