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
1392.1067824074 Days until the end of MDR transition period
> 230 Medical Device Standards
60 + XEC Guidances and Specifications

Agile Development of Medical Software in Compliance With Regulatory Requirements

Online Event on October 5th, 2021

Is it true that an agile approach to software development for software that is a medical device cannot be used in compliance with the MDR? The answer is: “No. This is not true.”
Find out more in our online workshop.

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.