FDA has published a 20-page white paper on how to set up certification as a medical device of machine-learning software (SaMD). Continue reading
medical device
Why the medical software certification will revolutionise the market in EU
As foreseen by the new Medical Devices European Rules (UE 2017/45), to be operational from 26 May 2020, and by the Court of Justice sentence of 7 December 2017, medical software shall be certified as medical devices (MD) class IIA (with the exception of software aimed to archive, store and transmit data without any data elaboration and added value). This will have a great impact on the market. Continue reading
