SaMD (Software as a Medical Device)
31
Mar
Are you developing software for healthcare applications? Understanding SaMD classification is crucial to your ...
31
Mar
SaMD Classification and Conformity Assessment: A Comprehensive Analysis of UK and EU Regulatory Frameworks
I. Introduction Software as a Medical Device (SaMD) is defined as “software intended to be used for one or more medical purposes without being part of a hardware medical device” (IMDRF, 2013). The regulation of SaMD presents unique challenges due…







