Page 420 - Safety Risk Management for Medical Devices

Index 399

Potential Hazards, 79 risk analysis, 93
Pre-risk, 162, 172 safety standard, 171
controls, 162 Production information, 193
Preclinical study, 185 Production monitoring, 195 196, 198
Preliminary hazard analysis (PHA), 49, 74, 77 80, benefits of postmarket surveillance, 199
172, 224 225, 286 308 feedback to preproduction risk management,
methodology, 78 80 197 199
identify system hazards, 78 80 frequency of risk management file review, 197
safety characteristics, 78 postmarket risk management, 196 197
revisiting, 172 Proper sizing, 38
Preproduction Protective measure, 144, 165, 173
phase, 195 Protocol, 184
risk management, 196 PubMed databases, 64
feedback to, 197 199 Pulley, 153
Pressure tank, 70 failure mode of, 153f
Primary faults, 70
Primary function identification Q
in DFMEA, 95 QC testing. See Quality control testing (QC
in PFMEA, 104 testing)
in UMFMEA, 113 QMS. See Quality management system
Primary operating function, 32 34 (QMS)
Principal output of FTA, 68 Qualitative method, 157, 173 174
Probability, 19 20, 158t, 159t risk evaluation for, 173
of benefit, 188 189 Quality
Procedure-related harms, 189 of clinical data, 189
Process Failure Modes and Effects Analysis system regulations, 4
(PFMEA), 80 81, 103 108 Quality control testing (QC testing), 175 176
detectability ratings, 109t, 265, 318 324 Quality management system (QMS), 29, 52, 177
occurrence ratings, 108t Quantitative analysis, 69 70
RPN table, 109t Quantitative method, 159 161, 174
template, 250 254 risk evaluation for, 174
workflow, 104 108 Quantitative risk
analysis, 105 108 estimation, 47
identify primary and secondary functions, management method, 174
104
PFD, 104 105 R
set scope, 104 RACT. See Risk Assessment and Control Table
Process flow diagram (PFD), 104 105 (RACT)
Process metrics, 219 Ratings assigning, 114
Product Reasonableness checks, 38
description of Vivio, 265 266 Reasonably foreseeable misuse,
design process, 119 12 13, 111
development Reliability, 121, 137, 147, 176
process, 221 Residual risks
team, 169, 225 estimation, 189
quality, 86 individual and overall, 174
reliability, 86 Risicare,15
requirements of Vivio, 266 267 Risk, 3 4, 11, 15, 157, 161, 163, 206