Conformity Assessment • VDE Medical Software

‘Conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled (Art. 2 (40) EU MDR)

Risk Classification of a Medical App
Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!
Market Access for Artificial Intelligence in Medicine
How does current regulation for market access fit with artificial intelligence in medicine? Find out more by a practical example.
Technical Documentation: See the Opportunities, not the Challenges!
The technical documentation of medical devices in the EU must be revised. We tell you what to keep an eye on and how to make it a success!
Cyber Security Threats in Healthcare
Cyber security threats affect medical device safety and patient protection. Learn here how to perform best regarding risk management.
Traceability of Medical Devices
Traceability plays a key role in increasing the safety of medical devices. Now, Unique Device Identification (UDI) also applies in Europe.

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