With the advancement of medical technology, more and more Medical device software (MDSWs) that work in combination with hardware are being designed and launched for various medical uses and it becomes imperative to comply with the changing regulations. Medical Device Software can have hardware as an integral part or as an accessory or as an independent medical device provided in system packs. Medical device software combined with hardware can be placed on the market in various combinations and are accordingly classified and subjected to regulatory pathways by medical device regulations.





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