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GHTF/AHWG-GRM/N1R13:2011 GHTF SC - Ad Hoc - Regulatory Model - April 2011 - PDF (983kb)

赵静曼 5/14/2022 浏览 317 GHTF/AHWG-GRM/N1R13:2011 全球范围

标准简介

GHTF SC - Ad Hoc - Regulatory Model - April 2011 - PDF (983kb)[附网盘链接]是于13 April 2011发布的GHTF标准，适用于全球范围。

标准截图

GHTF SC - Ad Hoc - Regulatory Model - April 2011 - PDF (983kb)[附网盘链接]
GHTF SC - Ad Hoc - Regulatory Model - April 2011 - PDF (983kb)[附网盘链接](截图)

 

标准文档说明

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标准部分原文

GHTF Ad Hoc Working Group 2011 GHTF/AHWG-GRM/N1R13:2011

__________________________________________________________________________________________________

Table of Contents

1 INTRODUCTION 4

2 RATIONALE, PURPOSE AND SCOPE 4

2.1 Rationale 4

2.2 Purpose 5

2.3 Scope 5

3 DEFINITIONS 5

4 EVOLUTION OF THE GHTF REGULATORY MODEL 5

5 THE LIFE CYCLE OF A MEDICAL DEVICE 6

6 ASPECTS OF THE GHTF REGULATORY MODEL 9

6.1 Use of the GHTF Regulatory Model and Alternative Models 9

6.2 Current Regulatory Paradigms of the GHTF Founding Members 9

6.3 Roles and Responsibilities of National Competent Authorities (NCA), Conformity Assessment

Bodies (CAB), and Manufacturers 10

7 ELEMENTS OF THE GHTF MODEL 12

7.1 The fundamental, harmonized elements of the GHTF Regulatory Model 12

7.2 Other important elements of the GHTF Regulatory Model 12

7.3 Additional regulatory elements not within the scope of the current work of the GHTF 12

8 GRAPHIC REPRESENTATIONS OF THE GHTF REGULATORY MODEL 12

8.1 Flow Chart Format 13

8.2 Combined Representation of the GHTF Regulatory Model 16

9 GHTF STUDY GROUPS AND RELATED DOCUMENTS 17

9.1 Pre-market Evaluation 17

9.2 Post-market Surveillance/Vigilance 18

9.3 Quality Systems 19

9.4 Auditing 20

9.5 Clinical Safety/Performance 21

10 THE GHTF REGULATORY MODEL DYNAMICS AND INTERRELATIONSHIPS 22

11 OUTLINE OF PROGRESSIVE IMPLEMENTATION OF ELEMENTS OF THE GHTF

REGULATORY MODEL 23

11.1 Basic level framework: 24

11.2 Medium level framework: 25

11.3 Highest level framework: 25

12 REFERENCES 26

Date: 13 April 2011 Page 2 of 27

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