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.
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.
Thorough analysis of the intended purpose provides essential evidence for stand-alone software being a medical device on its own.
Software can be a medical device. This has considerable consequences for product liability. The good news: manufacturers can manage the risks.