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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IMDRF/GRRP WG/N47 FINAL:2018 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - PDF (260kb)
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - PDF (260kb)[附网盘链接]是IMDRF Good Regulatory Review Practices Group于31 October 2018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。
5/18/2022 点赞 0 浏览 706 评论 0 -
GHTF/AHWG-GRM/N1R13:2011 GHTF SC - Ad Hoc - Regulatory Model - April 2011 - PDF (983kb)
GHTF SC - Ad Hoc - Regulatory Model - April 2011 - PDF (983kb)[附网盘链接]是Ad Hoc GHTF SC Regulatory Model Working于13 April 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。
5/14/2022 点赞 0 浏览 316 评论 0 -
IMDRF/REGISTRY WG/N33FINAL:2016 Principles of International System of Registries Linked to Other Data Sources and Tools - PDF (873kb)
Principles of International System of Registries Linked to Other Data Sources and Tools - PDF (873kb)[附网盘链接]是IMDRF Patient Registries Working Group于30 September 2016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。
5/8/2022 点赞 0 浏览 350 评论 0 -
IMDRF/PMD WG/N49 FINAL:2018 Definitions for Personalized Medical Devices - PDF (165kb)
Definitions for Personalized Medical Devices - PDF (165kb)[附网盘链接]是IMDRF Personalized Medical Devices于18 October 2018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。
5/7/2022 点赞 0 浏览 270 评论 0 -
IMDRF/GRRP WG/N61FINAL:2020 Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (785kb)
Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (785kb)[附网盘链接]是IMDRF GRRP Working Group于25 September 2020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。
5/3/2022 点赞 0 浏览 284 评论 0 -
IMDRF/IVD WG/N64FINAL:2021 (formerly GHTF/SG1/N045:2008) Principles of In Vitro Diagnostic (IVD) Medical Devices Classification - PDF (213kb)
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification - PDF (213kb)[附网盘链接]是IMDRF IVD Working Group于21 January 2021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。
4/23/2022 点赞 0 浏览 414 评论 0 -
IMDRF MDCE WG/N65FINAL:2021 Post-Market Clinical Follow-Up Studies - PDF (132kb)
Post-Market Clinical Follow-Up Studies - PDF (132kb)[附网盘链接]是Medical Device Clinical Evaluation Working Group于25 March, 2021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。
4/18/2022 点赞 0 浏览 441 评论 0 -
IMDRF/PMD WG/NSSFINAL:2020 Personalized Medical Devices - Regulatory Pathways - PDF (612kb)
Personalized Medical Devices - Regulatory Pathways - PDF (612kb)[附网盘链接]是IMDRF Personalized Medical Devices于18 March 2020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。
4/12/2022 点赞 0 浏览 252 评论 0 -
IMDRF/GRRP WG/N59FINAL:2020 Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (730kb)
Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (730kb)[附网盘链接]是IMDRF GRRP Working Group于18 March 2020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。
4/11/2022 点赞 0 浏览 310 评论 0 -
IMDRF/RPS WG/N19 FINAL:2016 Common Data Elements for Medical Device Identification - PDF (747kb)
Common Data Elements for Medical Device Identification - PDF (747kb)[附网盘链接]是IMDRF RPS Working Group于24 March 2016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。
4/10/2022 点赞 0 浏览 300 评论 0 -
IMDRF/AE WG/N43FINAL:2020 (Edition 4) Terminologies for Categorized Adverse Event Reporting (AER) terms, terminology and codes - PDF (1.21Mb)
Terminologies for Categorized Adverse Event Reporting (AER) terms, terminology and codes - PDF (1.21Mb)[附网盘链接]是IMDRF Adverse Event Terminology Working Group于18 March 2020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。
4/10/2022 点赞 0 浏览 383 评论 0 -
IMDRF/GRRP WG/N66FINAL:2021 Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews - PDF (1.2Mb)
Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews - PDF (1.2Mb)[附网盘链接]是IMDRF Good Regulatory Review Practices Working于24 June 2021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。
4/9/2022 点赞 0 浏览 298 评论 0 -
IMDRF/MDSAP WG/N4FINAL:2013 Competence and Training Requirements for Auditing Organizations - PDF (232kb)
Competence and Training Requirements for Auditing Organizations - PDF (232kb)[附网盘链接]是IMDRF MDSAP Working Group于9 December 2013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。
4/9/2022 点赞 0 浏览 276 评论 0 -
GHTF/SG5/N5:2012 Reportable Events During Pre-Market Clinical Investigations - PDF (196kb)
Reportable Events During Pre-Market Clinical Investigations - PDF (196kb)[附网盘链接]是Study Group 5 of the Global Harmonization Task Force于August 1 0 1h, 20 12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。
4/9/2022 点赞 0 浏览 234 评论 0 -
IMDRF/RPS WG/N32 FINAL: 2015 Strategic Assessment of Electronic Submission Messaging Formats - PDF (242Kb)
Strategic Assessment of Electronic Submission Messaging Formats - PDF (242Kb)[附网盘链接]是IMDRF RPS WG于2 October 2015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。
4/9/2022 点赞 0 浏览 282 评论 0