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Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls

A proposed document has been released by the International Medical Device Regulators Forum (IMDRF) Standalone Medical Device Software Harmonization (SaMD) Working Group for public comment.

This consultation is now closed.

Working Group Chair: Bakul Patel

Thank you very much for your contribution aiming at the validation of this IMDRF document.