Legal Requirements for Medical Software
Our resources of legal requirements for medical software help you to find all important laws, guidelines, and standards. Read more
Tag: MEDDEV
Risk Classification of a Medical App
Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example! Read more
How to Perform Clinical Evaluation of Medical Software
Manufacturers must do a clinical evaluation of a medical device before they can market it in Europe. Find out what you need to keep in mind. Read more
Stand-Alone Software as Medical Device
Thorough analysis of the intended purpose provides essential evidence for stand-alone software being a medical device on its own. Read more
Medical Device Classification: The Software Special
The EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes. Read more
Medical Device Clinical Trials
Medical device clinical trials are completely new regulated under the EU MDR. Manufacturers are faced with new challenges. Read more
