This guide provides recommendations for characterizing medical device software and assessing the risks specific to such software. It applies to all types of software that meet the definition of a medical device.

Learn more

Linked news

The European Commission has released a new update to its study on the availability of medical devices in Europe

21 Jul 2026 Read more

Reusable Surgical Instruments and EU Regulation 2017/745

21 Jul 2026 Read more

Biological Evaluation of Medical Devices

21 Jul 2026 Read more
This site is registered on wpml.org as a development site. Switch to a production site key to remove this banner.