Risk Classification of a Medical App
Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!
Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!
Cyber security threats affect medical device safety and patient protection. Learn here how to perform best regarding risk management.
Thorough analysis of the intended purpose provides essential evidence for stand-alone software being a medical device on its own.
Medical device certification is a prerequisite for market access in Europe. Use this checklist to start certification based on the new EU MDR.
You have to do with medical software and feel lost in regulation? Don’t give up. Get guidance with our latest book.