赵静曼
医疗器械高级设计工程师
| 等级 | 已入驻 | 排行 | 文章数 | 热度 |
|---|---|---|---|---|
| 12 | 1 年 | 3 | 126 | 0 |
以下是作者 赵静曼 的最新文章
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GHTF/SG2/N57R8:2006 GHTF SG2 - Guidance - Content of Field Safety Notices - PDF (58kb)
GHTF SG2 - Guidance - Content of Field Safety Notices - PDF (58kb)[附网盘链接]是Study Group 2于27 June 2006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。
12/16/2021 点赞 0 浏览 633 评论 0 -
GHTF/SG2/ N38R19:2009 GHTF SG2 - National Competent Authority Report Exchange Program - July 2009 - PDF (59kb)
GHTF SG2 - National Competent Authority Report Exchange Program - July 2009 - PDF (59kb)[附网盘链接]是GHTF Study Group 2于July, 2009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。
12/11/2021 点赞 0 浏览 348 评论 0 -
GHTF/FD: 99-7 GHTF SG2 - Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative - PDF - (52kb)
GHTF SG2 - Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative - PDF - (52kb)[附网盘链接]是SG2于June 29, 1999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。
12/9/2021 点赞 0 浏览 204 评论 0 -
GHTF/SG3/N99-10:2004 (Edition 2) GHTF SG3 - QMS - Process Validation Guidance - January 2004 - PDF (162kb)
GHTF SG3 - QMS - Process Validation Guidance - January 2004 - PDF (162kb)[附网盘链接]是SG3于Edition 2 - January 2004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。
12/8/2021 点赞 0 浏览 963 评论 0 -
GHTF/SG2/N20R10:2002 GHTF SG2 - Medical Devices Post Market Surveillance National Competent Authority Report Exchange Criteria - PDF (143kb)
GHTF SG2 - Medical Devices Post Market Surveillance National Competent Authority Report Exchange Criteria - PDF (143kb)[附网盘链接]是Study Group 2于21 May 2002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。
12/8/2021 点赞 0 浏览 325 评论 0 -
GHTF/SG1/N78:2012 GHTF SG1 Principles of Conformity Assessment for Medical Devices - November 2012 - PDF (382kb)
GHTF SG1 Principles of Conformity Assessment for Medical Devices - November 2012 - PDF (382kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于November 2 , 2012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。
12/2/2021 点赞 0 浏览 319 评论 0 -
GHTF/SG1/N065:2010 GHTF SG1 - Registration of Manufacturers and Listing of Medical Devices - PDF (106kb)
GHTF SG1 - Registration of Manufacturers and Listing of Medical Devices - PDF (106kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于August 27, 2010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。
11/29/2021 点赞 0 浏览 400 评论 0 -
GHTF/SG1/N046:2008 GHTF SG1 - Principles of CA for IVD Medical Devices - July 2008 - PDF (87kb)
GHTF SG1 - Principles of CA for IVD Medical Devices - July 2008 - PDF (87kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于July 31, 2008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。
11/20/2021 点赞 0 浏览 585 评论 0 -
GHTF/SG1/N046:2008 GHTF SG1 - Principles of CA for IVD Medical Devices - July 2008 - PDF (87kb)(1)
GHTF SG1 - Principles of CA for IVD Medical Devices - July 2008 - PDF (87kb)(1)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于July 31, 2008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。
11/16/2021 点赞 0 浏览 285 评论 0 -
GHTF/SG1/N055: 2009 GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer - PDF (41kb)
GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer - PDF (41kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于March 26, 2009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。
11/6/2021 点赞 0 浏览 1049 评论 0 -
GHTF/SG1/N071:2012 GHTF SG1 - Definition of Terms Medical Device and In Vitro Diagnostic Medical Device - May 2012 - PDF (240kb)
GHTF SG1 - Definition of Terms Medical Device and In Vitro Diagnostic Medical Device - May 2012 - PDF (240kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于May 16 , 2012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。
10/29/2021 点赞 0 浏览 825 评论 0 -
GHTF/AHWG-UDI/N2R3:2011 GHTF SC - Unique Device Identification System - September 2011 - PDF (104kb)
GHTF SC - Unique Device Identification System - September 2011 - PDF (104kb)[附网盘链接]是GHTF SC UDI Ad Hoc Working Group于September 16, 2011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。
10/25/2021 点赞 0 浏览 289 评论 0 -
GHTF/SC/N2R12:2010 GHTF Roles and Responsibilities - PDF (168KB)
GHTF Roles and Responsibilities - PDF (168KB)[附网盘链接]是GHTF Steering Committee于21 April 2010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。
10/19/2021 点赞 0 浏览 240 评论 0 -
GHTF/SC/N3R11:2010 GHTF Operating Procedures - PDF (164kb)
GHTF Operating Procedures - PDF (164kb)[附网盘链接]是GHTF Steering Committee于4 November 2010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。
10/7/2021 点赞 0 浏览 278 评论 0 -
IMDRF MDCE WG/N55 FINAL:2019 (formerly GHTF/SG5/N1R8:2007) Clinical Evidence - Key Definitions and Concepts - PDF (185kb)
Clinical Evidence - Key Definitions and Concepts - PDF (185kb)[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。
10/5/2021 点赞 0 浏览 813 评论 0