gmed newsletter v16 1Over the past decades use of software as a medical device increased exponentially as it undoubtedly helps to improve patient health. In parallel, development and application of regulatory requirements strengthen controls over medical devices specifically medical device software.

The European Medical Device Regulations (EU MDR) introduces new classification rules for medical device software. This newsletter will cover qualification and classification of software as medical device under Regulation (EU) 2017/745.




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