Conformity Assessment - VDE Medical Devices and 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)

Market Access for Medical Devices and Software
VDE MeSo offers practical support for the approval and certification of medical devices and software. We help you to bring your product to market faster and more efficiently.
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!
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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