Medical Devices and Software - VDE Medical Devices and Software

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

36.228854166667 Days until MDR application

> 230 Medical Device Standards

60 + XEC Guidances and Specifications

Regulatory Affairs for AI Applications in Medical Devices

Online Event, June 22nd, 2021

Head with Gear Wheels symbolizing AI (Artificial Intelligence)

The use of AI blurs the determination of classic software products because the training data alters the algorithm. Hence, all stakeholders are facing new challenges: the potentially continuing modifications as well as being very much depended on carefully selected training data. Therefore, currently AI algorithms need to be implemented in a frozen state in medical devices to receive clearance for US or EU market access.

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.

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