This workshop for startups and SMEs in the digital health sector will focus on the medical device regulatory landscape. It will help developers of medical and health-related apps and software to understand the importance of considering the medical device regulatory framework in the digital health sector.

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By using case studies, the following issues will be explained:

  • When does medical software fall under the medical device directive?
  • How to classify medical device software?
  • Which key regulatory standards are mandatory?
  • What is the impact of the new regulation on medical device software?

The presentation is followed by a Q&A session.

More information

EU-funded eHealth Hub project