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首页 ISO标准FDA标准国家标准地方标准GHTF标准行业标准
  • GHTF GHTF SG3 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange - Novemeber 2012 - PDF (457kb)

    GHTF GHTF SG3 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange - Novemeber 2012 - PDF (457kb)

    GHTF SG3 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange - Novemeber 2012 - PDF (457kb)[附网盘链接]是The Global Harmonization Task Force于当前发布的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。

    赵静曼 7/31/2022 浏览 216 GHTF 世界范围
  • GHTF GHTF SG1 - Standards in Assessment of Medical Devices - March 2008 - PDF (128kb)

    GHTF GHTF SG1 - Standards in Assessment of Medical Devices - March 2008 - PDF (128kb)

    GHTF SG1 - Standards in Assessment of Medical Devices - March 2008 - PDF (128kb)[附网盘链接]是The Global Harmonization Task Force于过去发布的GHTF标准,适用于世界。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。

    赵静曼 7/29/2022 浏览 202 GHTF 世界
  • GHTF/SG2/N68R3: 2005 GHTF SG2 - Where to Send Adverse Event Reports - PDF (204kb)

    GHTF/SG2/N68R3: 2005 GHTF SG2 - Where to Send Adverse Event Reports - PDF (204kb)

    GHTF SG2 - Where to Send Adverse Event Reports - PDF (204kb)[附网盘链接]是GHTF Study Group 2于May 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。

    赵静曼 7/26/2022 浏览 224 GHTF/SG2/N68R3: 2005 全球
  • GHTF/SG2/N61R4:2004 GHTF SG2 - PMS Harmonization Chart - November 2004 - PDF (51kb)

    GHTF/SG2/N61R4:2004 GHTF SG2 - PMS Harmonization Chart - November 2004 - PDF (51kb)

    GHTF SG2 - PMS Harmonization Chart - November 2004 - PDF (51kb)[附网盘链接]是Study Group 2于November 2004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。

    赵静曼 7/25/2022 浏览 231 GHTF/SG2/N61R4:2004 全球
  • SG1(PD)/N055R6 GHTF SG1 - Definition of the Terms of Manufacturer - 26 February 2008 - PDF (41kb)

    SG1(PD)/N055R6 GHTF SG1 - Definition of the Terms of Manufacturer - 26 February 2008 - PDF (41kb)

    GHTF SG1 - Definition of the Terms of Manufacturer - 26 February 2008 - PDF (41kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于February 26, 2008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。

    赵静曼 7/16/2022 浏览 247 SG1(PD)/N055R6 世界范围
  • GHTF/SG2/N47R4:2005 GHTF SG2 - Review of Requirements on Postmarket Surveillance - PDF (187kb)

    GHTF/SG2/N47R4:2005 GHTF SG2 - Review of Requirements on Postmarket Surveillance - PDF (187kb)

    GHTF SG2 - Review of Requirements on Postmarket Surveillance - PDF (187kb)[附网盘链接]是Study Group 2于May 2005发布的GHTF标准,适用于世界。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。

    赵静曼 7/15/2022 浏览 249 GHTF/SG2/N47R4:2005 世界
  • IMDRF/SaMD WG/N12FINAL:2014 Software as a Medical Device Possible Framework for Risk Categorization and Corresponding Considerations - PDF (243kb)

    IMDRF/SaMD WG/N12FINAL:2014 Software as a Medical Device Possible Framework for Risk Categorization and Corresponding Considerations - PDF (243kb)

    Software as a Medical Device Possible Framework for Risk Categorization and Corresponding Considerations - PDF (243kb)[附网盘链接]是IMDRF Software as a Medical Device (SaMD) Working Group于18 September 2014发布的GHTF标准,适用于世界。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。

    赵静曼 7/13/2022 浏览 256 IMDRF/SaMD WG/N12 世界
  • IMDRFIMDSAP WG/N11FINAL:2014 MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - PDF (422kb)

    IMDRFIMDSAP WG/N11FINAL:2014 MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - PDF (422kb)

    MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - PDF (422kb)[附网盘链接]是IMDRF MDSAP Working Group于18 September 2014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。

    赵静曼 7/11/2022 浏览 189 IMDRFIMDSAP WG/N11 世界范围
  • GHTF Glossary and Definition of Terms Used in GHTF Documents - PDF (163KB)

    GHTF Glossary and Definition of Terms Used in GHTF Documents - PDF (163KB)

    Glossary and Definition of Terms Used in GHTF Documents - PDF (163KB)[附网盘链接]是GHTF于之前发布的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。

    赵静曼 7/10/2022 浏览 183 GHTF 世界范围
  • IMDRF/UDI WG/N48 FINAL: 2019 Unique Device Identification system (UDI system) Application Guide - PDF (3.53Mb)

    IMDRF/UDI WG/N48 FINAL: 2019 Unique Device Identification system (UDI system) Application Guide - PDF (3.53Mb)

    Unique Device Identification system (UDI system) Application Guide - PDF (3.53Mb)[附网盘链接]是IMDRFUDI WG于21 March 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。

    赵静曼 7/6/2022 浏览 336 IMDRF/UDI WG/N48 全球
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热门推荐

GHTF GHTF SG3 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange - Novemeber 2012 - PDF (457kb)
GHTF GHTF SG1 - Standards in Assessment of Medical Devices - March 2008 - PDF (128kb)
GHTF/SG2/N68R3: 2005 GHTF SG2 - Where to Send Adverse Event Reports - PDF (204kb)
GHTF/SG2/N61R4:2004 GHTF SG2 - PMS Harmonization Chart - November 2004 - PDF (51kb)
SG1(PD)/N055R6 GHTF SG1 - Definition of the Terms of Manufacturer - 26 February 2008 - PDF (41kb)
GHTF/SG2/N47R4:2005 GHTF SG2 - Review of Requirements on Postmarket Surveillance - PDF (187kb)
IMDRF/SaMD WG/N12FINAL:2014 Software as a Medical Device Possible Framework for Risk Categorization and Corresponding Considerations - PDF (243kb)
IMDRFIMDSAP WG/N11FINAL:2014 MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - PDF (422kb)
GHTF Glossary and Definition of Terms Used in GHTF Documents - PDF (163KB)
IMDRF/UDI WG/N48 FINAL: 2019 Unique Device Identification system (UDI system) Application Guide - PDF (3.53Mb)
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