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).
In this article we discuss how Usability Engineering based on IEC 62366 leads to a better and compliant medical device.
In this article we give an overview of the software life cycle of medical devices and the corresponding standards.
The GDPR is legal basis for data protection in Europe. You should adopt GDPR principles directly into the design of your medical devices.
Software can be a medical device. This has considerable consequences for product liability. The good news: manufacturers can manage the risks.
Medical device manufacturers must implement the new EU MDR. Here you will find an overview to get things going.
Medical device certification is a prerequisite for market access in Europe. Use this checklist to start certification based on the new EU MDR.