Standard - VDE Medical Devices and Software

Standards are documents that describe technical requirements for products or process requirements in a formal manner with the aim of achieving high levels of safety, security, quality and compatibility.

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.
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.
Software Design for Segregation
Segregation is an important strategy in software development for reducing complexity. Find out how to apply segregation to your software!

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