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161 resources

IMDRF/Registry WG/N42: Methodological Principles in the Use of International Medical Device Registry Data

IMDRF Information document 2017-03-16 IMDRF Documents

Information document published 2017 by IMDRF.

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IMDRF RPS WG/N45: Data Exchange Guidelines – Common Data Elements for Medical Device Identification

IMDRF Information document 2017-03-16 IMDRF Documents

Information document published 2017 by IMDRF.

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IMDRF/SaMD WG/N41: Software as a Medical Device (SaMD): Clinical Evaluation

IMDRF Technical document 2017-09-21 IMDRF Documents

Technical document published 2017 by IMDRF.

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IMDRF/Registry WG/N46: Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making

IMDRF Information document 2018-03-27 IMDRF Documents

Information document published 2018 by IMDRF.

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IMDRF/RPS WG/N50: Round 2, RPS Beta Testing Report

IMDRF Information document 2018-07-27 IMDRF Documents

Information document published 2018 by IMDRF.

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IMDRF/PMD WG/N49: Definitions for Personalized Medical Devices

IMDRF Technical document 2018-11-07 IMDRF Documents

Technical document published 2018 by IMDRF.

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IMDRF/Standards WG/N51: Optimizing Standards for Regulatory Use

IMDRF Technical document 2018-11-12 IMDRF Documents

Technical document published 2018 by IMDRF.

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IMDRF/RPS WG/N27 FINAL:2019: Assembly and Technical Guide for IMDRF Table of Contents Submissions

IMDRF Information document 2019-03-20 IMDRF Documents

Information document published 2019 by IMDRF.

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IMDRF/RPS WG/N27: Assembly and Technical Guide for IMDRF Table of Contents Submissions (Archived)

IMDRF Technical document 2019-03-20 IMDRF Documents

Technical document published 2019 by IMDRF.

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IMDRF/UDI WG/N53: Use of UDI Data Elements across different IMDRF Jurisdictions

IMDRF Information document 2019-03-21 IMDRF Documents

Information document published 2019 by IMDRF.

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