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