Transcription of 'Software as a Medical Device': Possible Framework …
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'Software as a Medical Device': Possible Framework …
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. Co yright 2014 by the International Medical Device Re ulators Forum. IMDRF/SaMD WG/N12 FINAL:2014 _____ _____ 18 September 2014 Page 2 of 30 Table of Contents Introduction.
The objective of this document is to introduce a foundational approach, harmonized vocabulary and general and specific considerations for manufacturers, regulators, and users alike to address
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