Software Life Cycle - VDE Medical Devices and Software

The software life cycle usually starts with the beginning of first exploratory studies / product ideas. As an approximate rule the end of the life cycle can be equated with the end of the documentation storage as specified in the EU MDR.

Synonyms:

life cycle

Clinical Evaluation of Medical Devices
Get an overview of the most important elements of a clinical evaluation of medical devices according to the EU Medical Device Regulation (MDR).
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.

« Back to Glossary Index

Write a comment or suggest a term! Cancel reply