Medical Device • VDE Medical 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.

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!
Clinical Evaluation of Medical Devices
Learn in our workshop how to be compliant with the MEDDEV guideline and MDR requirements for clinical evaluation of your medical device.
Software Life Cycle: How do I meet the Regulatory Requirements?
Development of medical software must follow the life cycle principles. Learn in our workshop how to implement the respective standards.

« Back to Glossary Index

Write a comment or suggest a term! Cancel reply