GHTF/SG2/N61R4:2004 GHTF SG2 - PMS Harmonization Chart - November 2004 - PDF (51kb)
标准简介
GHTF SG2 - PMS Harmonization Chart - November 2004 - PDF (51kb)[附网盘链接]是Study Group 2发布的GHTF标准，适用于全球。标准截图
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标准文档说明
标准文档类型为GHTF SG2 - PMS Harmonization Chart - November 2004 - PDF (51kb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
SG2 WD
1.0 Scope and introduction
GHTF SG2 N16R5 (the SG2 Charge and Mission Statement) identified a number of tasks for
SG2. The study group was to “define requirements for a common medical device vigilance system and
provide an international protocol to define and facilitate the transmission of vigilance information on a
global basis. “ This has been the focus of SG2 for a number of years and a number of approved
documents have been produced.
Another task identified in the Charge and Mission statement was to “…define recommendations
and guidelines of post-market surveillance”. This document represents the outcome of discussions
on Post Market Surveillance (PMS) within SG2. The first step was to identify post-market
surveillance activities and related regulations (summarized in SG2-N47) and then determine if
there was a potential for harmonization of those activities in some way. This document reviews
all post-market surveillance areas with a view to harmonization
2.0 References
GHTF SG2 N47: Review of Current Requirements on Postmarket Surveillance
GHTF SG2 N16R5: SG2 Charge and Mission Statement
3.0 Definitions
none
September 2004 Page 4 of 7
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