Medical Devices
and Software

VDE offers hands-on support for the approval and certification of medical devices and software.
Get your product to market faster.

Consulting

Practical support for the approval and certification of medical devices

Coaching

Hands-on workshops on all aspects of market access for medical devices

Know-How

Latest expertise on medical device regulation in our blog

98000 Words in MDR (EU) 2017/745
1310.0131712963 Days until the end of MDR transition period
> 230 Medical Device Standards
60 + XEC Guidances and Specifications

Help, It’s a Medical Device! Certification For Newbies & Start-ups

Web-Seminar on December 1st, 2021

Are you developing a medical device? In our online seminar, we answer your most urgent questions about certification!

627 FDA Software Recalls (2011-2015)
> 400 CFR 21 Parts
> 1400 Recognised Consensus Standards
622 FDA Medical Device Guidances

Medical Apps or Software

Classification and Approval as Medical Device

Software like a medical app that has a medical purpose is legally a medical device.

Testing and Certification

of medical devices and software

The VDE Institute helps you comply with the regulatory guidelines and obtain internationally recognized certifications.