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.

Software Classification: Insights in EU Guidance
The MDR caused uncertainty concerning software classification. We give you an exclusive insight into the upcoming EU guideline!
Usability Engineering: Regulatory Requirements and Product Optimization
Use and user errors are critical risks of medical devices. Learn in our workshop how to set up an efficient usability engineering.
[Video] How to Achieve MDR Compliance for Medical Apps
It's hard to achieve MDR compliance when developing medical apps. Learn in this presentation how to overcome this hurdle.
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.

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