How does the Medical Device Regulation (MDR) affect software development?

The ever-changing regulations and standards and the higher importance of software in devices and systems used in healthcare have made medical software development very challenging. The Medical Device Regulation (MDR) aims to harmonize the European market for medical devices.

The MDR will significantly increase the responsibilities of medical device manufacturers and will give a higher risk classification for an increasing number of medical device software systems. As a result, devices and systems will become more secure.

In this guide you'll find answer eg. to the following questions:

  • What is the MDR?
  • How it affects software development?
  • Which are the most important points to consider?

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