Juha Sippola

Medical device manufacturers have long been following the timeline of the implementation obligations of the MDR and the predecessor MDD. The EU still has not announced an exact date for the end of MDD support, but it is...

The Medical Device Regulation (MDR) aims to harmonize the European market for medical devices.

This blog series discusses the Medical Device Regulation (MDR) in brief and how it affects software development for medical devices. This part discusses the effects of the MDR on your Quality Management System (QMS).

This blog series discusses the Medical Device Regulation (MDR) in brief and how it affects software development for medical devices. In this first part we will look at the MDR in brief and the software qualification and...