Transcription of Final Document: Software as a Medical Device (SaMD ...
{{id}} {{{paragraph}}}
Example: dental hygienist
Final Document: Software as a Medical Device (SaMD ...
imdrf / samd WG/N41 Final :2017 Final Document Title: Software as a Medical Device ( samd ): Clinical Evaluation Authoring Group: Software as a Medical Device Working Group Date: 21 September 2017 J. Patrick Stewart, 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. Copyright 2017 by the International Medical Device Regulators Forum. imdrf / samd WG/N41 Final :2017 _____ 21 September 2017 Page 2 of 30 Table of Contents Executive Summary.
The IMDRF has acknowledged that software is an increasingly critical area of healthcare product development and has developed a series of documents concerning the definition, the categorization, and the application of quality systems principles of SaMD. In 2013, IMDRF’s SaMD Working Group released SaMD N10 [1] Software as a Medical Device
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: