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
290.04481481481 Days until MDR application
> 200 Medical Device Standards
20 + XEC Guidances and Specifications

Legal Requirements for Medical Devices

Laws, Guidelines, Standards, and other Resources

Person standing, having a a folder with a scale symbol on it, in his hands. In the background some shelves with many books on it. Altogether symbolizin a person taking care of the legal requirements and most importent documents for market access of medical software.

Get this list with all important resources of legal requirements for medical software. Amongst others you will find up-to-date links to laws, corresponding guidelines as well as harmonized standards for medical software.

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

Safety requirements of clinical thermometers and febrile screening thermographs

Free web-seminar | Sept. 24th 2020 | 10:00 AM

 

Devices intended to measure body temperature need to be tested according to ISO 80601-2-56 and IEC 80601-2-59. In our free web-seminar VDE Testing and Certification will give you an overview on these safety requirements.

Learn more

Testing and Certification

of medical devices and software

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

Learn more