Medical Device - VDE Medical Devices and Software

A medical device is an instrument, apparatus, appliance, software, implant, reagent, material or other article intended for the use with human beings for medical purposes that are specified in more detail in Art. 2 EU MDR.

Clinical Evaluation of Medical Devices
Get an overview of the most important elements of a clinical evaluation of medical devices according to the EU Medical Device Regulation (MDR).
Usability Engineering for Medical Devices: IEC 62366
In this article we discuss how Usability Engineering based on IEC 62366 leads to a better and compliant medical device.
Software Life Cycle for Medical Devices: IEC 62304
In this article we give an overview of the software life cycle of medical devices and the corresponding standards.
Risk Management for Medical Devices: ISO 14971
The risks of a medical device must be acceptable in comparison to its benefits. Manufacturers must therefore carry out a risk management process. Read how this works in this article.
Postponed to 2021: VDE Medical Software
The MeSo expert community will meet on 13 May 2020 in Frankfurt. Find out which regulatory requirements you have to meet now and in the future and how to implement them efficiently.

« Back to Glossary Index

Write a comment or suggest a term! Cancel reply