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.

Services

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
120.28365740741 Days until MDR application
> 230 Medical Device Standards
60 + XEC Guidances and Specifications

The EU Medical Device Regulation (MDR)

What is changing?

The European Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) and the Directive on Active Implantable Medical Devices (AIMDD). This article provides an overview of the major changes and the current status of implementation.

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.

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

Testing and Certification

of medical devices and software

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