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
Tag: intended purpose
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
Product Liability and Medical Software: Fortunately You Can Insure Yourself
Software can be a medical device. This has considerable consequences for product liability. The good news: manufacturers can manage the risks. 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
