by Mazur, B | Last updated Mar 29, 2023 | INSIGHTS, MEDICAL, REGULATORY, Software
What are the key regulatory challenges of Software as a Medical Device (SaMD)? Reading time 15 mins Key Points There is a lack of harmonisation between different regulatory bodies (e.g. FDA, MHRA, and EU MDR) as they define and categorise SaMD differently This changes...
by Mazur, B | Last updated Mar 29, 2023 | INSIGHTS, IoT, MEDICAL, Software
Top 5 uses of software as a medical device & the impacts on healthcare Reading time 11 mins Key Points Software as a medical device (SaMD) is a class of medical software designed to perform one or more medical functions without the need for actual hardware UK...
