Page 15 - Safety Risk Management for Medical Devices

xiv List of Figures

Figure 16.2 Automobile Subsystems 152
Figure 16.3 Engine Subsystems 152
Figure 16.4 Water Pump 153
Figure 16.5 Failure Mode of the Pulley 153
Figure 16.6 Failure Mode of the Water Pump 154
Figure 16.7 Failure Mode of the Engine 154
Figure 17.1 Example 3 3 3 Qualitative Risk Matrix 158
Figure 17.2 Example 5 3 5 Risk Matrix 159
Figure 17.3 ISO 14971, Fig E.1—Quantification of Risk 160
Figure 17.4 The BXM Five-level Risk Computation Method 160
Figure 23.1 Risk Benefit Comparison 190
Figure 24.1 Postmarket Versus Postproduction 193
Figure 25.1 Traceability Model 201
Figure 31.1 Identification of Essential Design Outputs 223
Figure 31.2 Risk Management and Product Lifecycle 224
Figure C.1 Vivio system architecture 267