Join us for the next #BHHSeries online event organized in collaboration with Asphalion on Wednesday March 24th at 6pm CET! This month’s episode will discuss “Medical Device Regulation (MDR) for medical software: Are you ready?”

The upcoming application of the Medical Device Regulation (MDR) on May 26th 2021 may signify your digital solution is subject of qualification as a Medical Device. Software as Medical Device (SaMD) manufacturers will face new challenges to comply with MDR new requirements.

In this episode, Asphalion‘s speakers Talyta Carteano, Medical Device Manager, and Dominique Monferrer, Medical Device Director, will discuss the lessons to be learned:

• Is your software a medical device? What you need to know about qualification and classification
• How is the regulatory approval process?
• Spanish manufacturers special requirements
• Do I need a Quality Management System?

Do you already have a question regarding MDR you would like to be addressed during this #BHHSeries? You can submit your question here!

Join this next episode of the #BHHSeries to discover more about the new legal framework and the implications in digital health sector. We hope to see you on Wednesday March 24 at 6pm CET here!

Go to the BHHSeries here >>