ISO 14971 Tramslated into Plain English

PART

TITLE 48 TABLE OF CONTENTS

PAGE

1

Introduction

3

2

Risk Management Dictionary

12

3

Establish Your Risk Management Framework

20

4

Perform a Risk Analysis for Each Medical Device

26

5

Evaluate Risk For Each Identified Hazardous Situation

33

6

Develop Risk Control Measures Whenever Risk Must Be Reduced

34

7

Evaluate the Overall Residual Risk Posed by Each Medical Device

40

8

Review Risk Management Process and Prepare Risk Management Report

42

9

Monitor Your Medical Device During Production and Post-production

43

10

Executive Summary of ISO 14971 Risk Management Standard

47

11

Executive Summary of ISO 14971 Annexes

53

12

License Agreement

59

Attention

Title 48 is 60 pages long. It is detailed, accurate, and complete,
and uses language that is clear, precise, and easy to understand.
We guarantee it. Title 48 will be delivered to you as an email
attachment and is available in both pdf and doc file formats.

Please use the following links to order Title 48 or to check other details.

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OTHER ISO 14971 PAGES

Introduction Risk Management Standard

Overview of Medical Device Risk Management Standard

Plain English Medical Device Risk Management Definitions

Medical Device Risk Management Standard in Plain English

Our Plain English Approach to Risk Management Standards

OTHER RELATED LIBRARIES

ISO 31000 2009 Risk Management Library

ISO 13485 Medical Device Quality Management Library


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