Go beyond theory
of market access!

Understand and implement all regulatory requirements
of software classified as a medical device.

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Get relevant expertise by reading our Blog, browsing through the medical software Glossary or chatting with our experts.

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Connect with Experts

Connect with international medical software experts in our Community and benefit from the experience of others.

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Receive Guidance

Receive customized training and guidance from our Partners to implement all regulatory requirements for your project.

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98000 Words in MDR (EU) 2017/745
250.24409722222 Days until MDR application
> 200 Medical Device Standards
10 + XEC Guidances and Specifications

What our partners say

About our range of services

Thorsten Prinz

"Regulatory of medical devices is a real hurdle, especially for small and medium-sized companies. Practical support from VDE Medical Software ensures your success."

Hans Christian Wenner

"Innovative medical devices need up-to-date approaches to satisfy current and future regulatory requirements."

Andreas Rösch

"In a constantly changing environment, we help our customers to plan and implement sophisticated medical device projects.”

Christian Schübel

"VDE Medical Software offers most reliable and current information accelerating market access.”

627 FDA Software Recalls (2011-2015)
> 400 CFR 21 Parts
> 300 Recognised Consensus Standards
712 FDA Medical Device Guidances

Get in touch

To arrange a consultation or workshop, send us a message or give us a phone call: +49 69 6308 349

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