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: embedded software
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
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
