ISO 14971 2007

PART

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

Title 48 is 60 pages long and comes in both pdf and MS Doc file formats