Page 422 - Safety Risk Management for Medical Devices

Index 401

of effectiveness, 185 186 harmonized standards, 24
of implementation, 184 185 ISO 14971 history and origins, 23 24
Risk management, 1 4, 6 7, 13 16, 25 27, vocabulary, 9 13, 9t
29 30, 41, 77, 88, 124, 159 160, 171, elaborations, 11 13
189, 195, 206 207, 209, 213 214, hazard theory, 13, 13f
216 220, 224 225, 229, 233, 236 reasonably foreseeable misuse, 12 13
analysis, 25 26 system types, 13 14
artifacts, 29 Risk Management File (RMF), 49, 53, 141
benefits, 5 additions, 142, 143t
business reasons, 5 7 frequency of RMF review, 197
avoiding recalls and field corrective actions, 6 Risk Management Plan (RMP), 49, 53 60, 78,
communications, 6 7 171, 173, 209, 236
cost efficiency, 5 6 considerations for risk reduction end-point, 60
CHL, 61 62 criteria for risk acceptability, 54 60
for combination medical devices, 231 of Vivio, 268 278
controls, 26 Risk Management Report (RMR), 51, 202,
verification, 27 369 375
evaluation, 26 Risk reduction, 40
FMEA in, 90 92 and compliance with IEC 62366 process
HAL, 62 66 end-points, 55 56
creating harms assessment list, 63 66 considerations for, 60
hazard identification, 60 61 with SOTA, 57f
integration of supplier input into, 154 155 without SOTA, 58f
legal and regulatory requirements, 4 5 RMF. See Risk Management File (RMF)
European Union, 4 5 RMP. See Risk Management Plan (RMP)
MDD/AIMDD and transition to EU MDR, RMR. See Risk Management Report (RMR)
5 Root-cause analysis, 195
United States, 4 RPN method, 101, 108, 116 117, 136
lifecycle relevance of, 224 225 DFMEA, 101t
mapping of terminologies, 205 206 merits for criticality ranking, 85 86
methodology, 41 PFMEA, 109t
monitoring, 27 UMFMEA, 117t
moral and ethical reasons, 7 Rule-based failure, 37
process metrics
comparison with historical projects, 219 S
issue detection history, 220 SAE. See Serious adverse event (SAE)
subjective evaluation, 220 Safety, 11, 16, 121, 123, 137, 221, 227
and product lifecycle, 224f characteristics, 78
relationship between UMFMEA and RACT, by design, 165, 173
92f impact, 96, 106
requirements, 206 207 capture end-effects with, 172
responsibilities, 52 information for, 165
RMF, 53 reliability, vs., 121
RMP, 53 60 requirements, 169
criteria for risk acceptability, 54 60 risks, 221
other considerations for risk reduction end- management, 2, 86 87
point, 60 safety-critical software development, 148 149
standards, 23, 213 safety-related failure mode, 223 224