Validation - VDE Medical Devices and Software

Provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. The product does the right thing.

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.
Market Access for Artificial Intelligence in Medicine
How does current regulation for market access fit with artificial intelligence in medicine? Find out more by a practical example.
Technical Documentation: See the Opportunities, not the Challenges!
The technical documentation of medical devices in the EU must be revised. We tell you what to keep an eye on and how to make it a success!
Risk Management for Medical Devices
Risk management in medical devices is an important contribution to patient safety. But how do you perform a risk management. We tell you!

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