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.
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.
Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).