chapter
20 Pages

Contents

Bibliography .......................................................................................44

Chapter 5 Safety and Risk Management ............................................................. 45

5.1 Risk ............................................................................................ 45 5.2 Deciding on Acceptable Risk .................................................... 47 5.3 Factors Important to Medical Device Risk Assessment ............ 47

5.3.1 Device Design and Manufacture ...................................48 5.3.2 Materials ........................................................................48 5.3.3 Device Users ..................................................................48 5.3.4 Human Factors ............................................................... 49 5.3.5 Medical Device Systems ............................................... 49

5.4 Risk Management ...................................................................... 49 5.5 The Risk Management Process ................................................. 49

5.5.1 Identifying the Risk Factors ..........................................50 5.5.2 Assessing Risk Probabilities and Risks

on the Project .................................................................50 5.5.3 Developing Strategies to Mitigate

Identied Risks .............................................................. 52 5.5.4 Monitoring Risk Factors ................................................ 52 5.5.5 Invoking a Contingency Plan ......................................... 53 5.5.6 Managing the Crisis ....................................................... 53 5.5.7 Recovering from the Crisis ............................................ 53

5.6 Tools for Risk Estimation .......................................................... 53 5.6.1 Hazard/Risk Analysis .................................................... 53 5.6.2 FMEA Process ............................................................... 55 5.6.3 FTA ................................................................................ 58

5.6.3.1 FTA Process .................................................... 58 5.6.3.2 Example of an FTA ......................................... 59

Bibliography ....................................................................................... 62

Chapter 6 Documents and Deliverables .............................................................. 63

6.1 Establishing Preliminary System Reliability Requirements ..... 63 6.2 Developing a Device Prole at the System Level .....................64