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'Software as a Medical Device': Possible Framework for ...

Title: IMDRF IMDRF/SaMD WG/N12 FINAL:2014 International Medical Device Regulators Forum Final Document "Software as a Medical Device": Possible Framework for Risk categorization and Corresponding Considerations Authoring Group: IMDRF Software as a Medical Device (SaMD) Working Group Date: 18 September 2014 YfhJ!L_ Jeffrey Shuren, IMDRF Chair This document was produced by the International Medical Device Regulators Forum. There are no restrictions on the reproduction or use of this document; however, incorporation of this document, in part or in whole, into another document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the International Medical Device Regulators Forum.

it uses risk management principles (e.g., principles in international standards) to identify generic risks for SaMD. • The categorization framework in this document is not a regulatory classification, nor implies a convergence of classifications rules. However, it does set a …

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