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 of the Barcelona Health Hub series, Asphalion‘s expert 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?
The Webinar will take place on the 24th of March, at 6:00 p.m. CET.
Do not hesitate to contact us should you need further information or assistance: [email protected]
Additionally, we would like to remind you that you can request a free 30 minutes consultation meeting here:
https://outlook.office365.com/owa/calendar/[email protected]/bookings/
Looking forward to seeing you at the webinar!
