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
Tag: medical device
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
GDPR Principles and Medical Software: Privacy by Design is King
The GDPR is legal basis for data protection in Europe. You should adopt GDPR principles directly into the design of your medical devices. Read more
CJEU Top Court Cases on Medical Devices
Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU). Read more
