最新 - GHTF标准
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GHTF/SC/N1R8:2005 GHTF Guiding Principles - PDF (490kb)
GHTF Guiding Principles - PDF (490kb)[附网盘链接]是GHTF Steering Committee于May 20, 2005发布的GHTF标准,适用于全球。本次分享的标准文档为高清PDF(文字版),标准文档内可搜索,可复制,可粘贴。本文结尾附网盘链接。
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IMDRF RPS WG/N45FINAL:2017 Data Exchange Guidelines - Common Data Elements for Medical Device Identification - PDF (1084kb)
Data Exchange Guidelines - Common Data Elements for Medical Device Identification - PDF (1084kb)[附网盘链接]是IMDRF RPS Working Group于16 March 2017发布的GHTF标准,适用于全球范围。本次分享的标准文档为高清PDF(文字版),标准文档内可搜索,可复制,可粘贴。本文结尾附网盘链接。
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IMDRF/GRRP WG/N40FINAL:2017 Competence, Training, and Conduct Requirements for Regulatory Reviewers - PDF (174kb)
Competence, Training, and Conduct Requirements for Regulatory Reviewers - PDF (174kb)[附网盘链接]是IMDRF Good Regulatory Review Practices于16 March 2017发布的GHTF标准,适用于全球。本次分享的标准文档为高清PDF(文字版),标准文档内可搜索,可复制,可粘贴。本文结尾附网盘链接。
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IMDRF MDCE WG/N57FINAL:2019 (formerly GHTF/SG5/N3:2010) Clinical Investigation - PDF (267kb)
Clinical Investigation - PDF (267kb)[附网盘链接]是Medical Device Clinical Evaluation Working Group于10 October 2019发布的GHTF标准,适用于全球范围。本次分享的标准文档为高清PDF(文字版),标准文档内可搜索,可复制,可粘贴。本文结尾附网盘链接。
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l l V I U f i r Device Regulators Forum Clinical Evaluation - PDF (322kb)
Clinical Evaluation - PDF (322kb)[附网盘链接]是Medical Device Clinical Evaluation Working Group于10 October 2019发布的GHTF标准,适用于全球。本次分享的标准文档为高清PDF(文字版),标准文档内可搜索,可复制,可粘贴。本文结尾附网盘链接。
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IMDRF/RPS WG/N27 FINAL:2019 Assembly and Technical Guide for IMDRF Table of Contents Submissions - PDF (886kb)
Assembly and Technical Guide for IMDRF Table of Contents Submissions - PDF (886kb)[附网盘链接]是Regulated Product Submissions Table of Contents WG于24 January 2019发布的GHTF标准,适用于世界范围。本次分享的标准文档为高清PDF(文字版),标准文档内可搜索,可复制,可粘贴。本文结尾附网盘链接。