Provision of objective evidence, that specified requirements have been fulfilled. The product does it right.
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- Usability Engineering for Medical Devices: IEC 62366In 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 62304In this article we give an overview of the software life cycle of medical devices and the corresponding standards.
- Market Access for Artificial Intelligence in MedicineHow 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 DevicesRisk management in medical devices is an important contribution to patient safety. But how do you perform a risk management. We tell you!