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).

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.
Usability Engineering for Medical Devices: IEC 62366
Inadequate usability of medical devices can lead to misuse and thus to harm or even death of patients. This also applies to software as a medical device. For this reason, manufacturers of medical devices are obliged to carry out a development process that is linked to usability engineering.
Software Life Cycle for Medical Devices: IEC 62304
In this article, we discuss what manufacturers must pay attention to when considering the software lifecycle and how the standards specifically help in this respect.

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