Page 415 - Safety Risk Management for Medical Devices

394 Index

Clinical evaluations, 188, 204 D
BRA in, 191 192 Data
Clinical functions, 211 212 gathering, 40
Clinical Hazards List (CHL), 53, 61 62, 78, 172, interface, 94
199 monitoring plan, 195
Clinical Investigation Plan (CIP), 204 publishing, 64
Clinical investigation(s), 203 204, 217 218 De Morgan’s theorem, 177
risk management for Deep brain stimulator, 54
clinical studies, 204 205 Delphi technique, 65 66
mapping of risk management terminologies, Design, 84
205 206 flaw, 235
risk documentation requirements, 208 output, 222
risk management requirements, process, 93
206 207 safe by, 165
terminology, 204 Design Failure Modes and Effects Analysis
risk management input to clinical (DFMEA), 80 81, 83, 92 102, 97t, 132,
documentation, 208t 151, 265, 309 317
of Vivio, 279 280 detectability ratings, 99t
Clinical methods, 189 information flow between FMEA levels, 93f
Clinical study, 185, 204 205, 217 occurrence ratings, 99t
Cochrane databases, 64 RPN table, 101t
Cognition Error, 32 34, 37 severity ratings, 98t
Combination medical devices, 231 template, 239 243
risk management for, 231 workflow, 93 102
Command faults, 70 analysis, 95 102
Command path, 70 identify primary and secondary functions, 95
Common cause failures set scope, 94 95
(CCFs), 67, 71 Designer errors, 84, 93
Communications, 6 7 Detectability (Det), 84 86, 108, 116, 135
Complex control Device master record (DMR), 222
system, 36 DFMEA. See Design Failure Modes and Effects
Concept testing, 175 Analysis (DFMEA)
Confirmation bias, 233 234 Direct Causes, 133
Conformite ´ Europe ´enne (CE), 5 Direct gate-to-gate connection, 75
Confusing control system. See Disease characteristics, 189
Complex control system Distinctions, 34
Control factors, 118 Distributed systems, 14, 91, 91f
Conundrum, 229 DMR. See Device master record (DMR)
Correct use, 32 34 Duration of benefit, 189
Corrective and Preventive Actions (CAPA), 49,
195 E
Corrosive process, 215 ECGs, 185
Cost efficiency, 5 6 EDOs. See Essential design outputs (EDOs)
Crestor, 16 Effectiveness, 32 34
Critical thinking, verification, 185 186
233 Electrocution, 63
Criticality matrix, 86, 86t Electronic thermometer, 83, 83f,87
Cut set, 68 Elevators, 165