Medical Software - VDE Medical Devices and Software

Software classified as a medical device or accessory according to the manufacturer’s intended purpose. Medical device software can be part of a medical device (embedded) or a medical device on its own (stand-alone).

Help, It’s a Medical Device! Certification For Newbies & Start-ups
Are you developing a medical device? In our web seminar, we will answer your most urgent questions about marketing authorization!
Agile Development of Medical Software
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.
Electrical Safety for Active Medical Devices: The IEC 60601-1 Standard
Medical devices that have an electrical power source must meet special safety requirements. The standard IEC 60601-1 describes these requirements and is therefore one of the most important and most extensive standards for medical devices.
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. This article gives an overview of the path from a software to a medical device with CE-marking.
Clinical Evaluation of Medical Devices according to MDR
Manufacturers of medical devices must carry out a clinical evaluation of their products in order to be allowed to market them in Europe. To do this, the manufacturer must use clinical data to check whether the medical device is safe and efficient.

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