Software as Medical Devices(English)

• an evidence-based framework for evaluation of therapeutic devices, based on ethical principles and clinical evidence considerations. Uses a sequential decision-making algorithm for identifying when an RCT should be performed to evaluate new therapeutic devices, and when other methods, such as observational study designs and registry-based approaches, are acceptable
• RCT, CEAR, CECP, CENELEC, EUDAMED, MDCG, NANDO, UDI
• Decision making, Medical technology (assessment), Epidemiology, Ethics, Evidence based medicine, Registry
• https://doi.org…000000000005053