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).

Usability Engineering for Medical Devices: IEC 62366
In this article we discuss how Usability Engineering based on IEC 62366 leads to a better and compliant medical device.
Software Life Cycle for Medical Devices: IEC 62304
In this article we give an overview of the software life cycle of medical devices and the corresponding standards.
Risk Management for Medical Devices: ISO 14971
The risks of a medical device must be acceptable in comparison to its benefits. Manufacturers must therefore carry out a risk management process. Read how this works in this article.
Postponed to 2021: VDE Medical Software
The MeSo expert community will meet on 13 May 2020 in Frankfurt. Find out which regulatory requirements you have to meet now and in the future and how to implement them efficiently.
Market Access for Medical Devices and Software
VDE MeSo offers practical support for the approval and certification of medical devices and software. We help you to bring your product to market faster and more efficiently.

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