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GHTF SG1 - Summary Technical Documentation …
www.imdrf.orgGHTF/SG1/N063:2011 . FINAL DOCUMENT . Global Harmonization Task Force . Title: Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In
Harmonization By Doing (HBD) Working Group …
www.jfmda.gr.jp*この日本語文書は参考のための仮翻訳で、正文は英文です。 仮訳. Harmonization By Doing (HBD) Working Group (WG) 4 . Summary Technical Documentation (STED) Proof of Concept (POC)
PROPOSED REVISED DOCUMENT - IMDRF
www.imdrf.orgSG1(PD)/N011R20 PROPOSED REVISED DOCUMENT Global Harmonization Task Force Title: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices