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EU IMDRF/SaMD WG/N41 FINAL:2017

Current

Current

The latest, up-to-date edition.

Software as a Medical Device (SaMD): Clinical Evaluation

Available format(s)

Hardcopy

Language(s)

English

Published date

21-09-2017

Free

This document focuses on the activities needed to clinically evaluate SaMD -- and relies on the reader to gain knowledge from the previous documents as a pre-requisite to this document.

DocumentType
Standard
Pages
30
ProductNote
This standard also refers to IMDRF SaMD N10, SaMD N12, SaMD N23, GHTF SG3 N18:2010, GHTF SG5 N1R8:2007, GHTF SG5 N2R8:2007, GHTF SG5 N3:2010, GHTF SG5 N4,
PublisherName
European Union
Status
Current

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