A group of medical device regulators and industry stakeholders from 10 countries has released a proposed framework for harmonizing international medical device regulations as they relate to software as a medical device (SaMD).
"SaMD is increasingly being used in a wide range of medical settings and for a wide range of medical purposes, and has become an innovative tool with the potential to enhance the quality of care," states the document. "There is a need for all stakeholders (manufacturers, users, and regulators) to have a common approach and understanding of SaMD risks and expected controls that promotes patient safety and public health."
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