Page 11 - Safety Risk Management for Medical Devices

x Contents

22. Verification of Risk Controls 183
22.1 Verification of Implementation 184
22.2 Verification of Effectiveness 185

23. Benefit Risk Analysis 187
23.1 Benefit Risk Analysis in Clinical Evaluations 191

24. Production and Postproduction Monitoring 193
24.1 Postmarket Risk Management 196
24.2 Frequency of Risk Management File Review 197
24.3 Feedback to Preproduction Risk Management 197
24.4 Benefits of Postmarket Surveillance 199

25. Traceability 201

26. Risk Management for Clinical Investigations 203
26.1 Terminology 204
26.2 Clinical Studies 204
26.3 Mapping of Risk Management Terminologies 205
26.4 Risk Management Requirements 206
26.5 Risk Documentation Requirements 208

27. Risk Management for Legacy Devices 209

28. Basic Safety and Essential Performance 211
28.1 How to Identify Basic Safety 211
28.2 How to Identify Essential Performance 211

29. Relationship Between ISO 14971 and Other Standards 213
29.1 Interaction With IEC 60601-1 213
29.2 Interaction With ISO 10993-1 214
29.3 Interaction With IEC 62366 216
29.4 Interaction With ISO 14155 217

30. Risk Management Process Metrics 219
30.1 Comparison With Historical Projects 219
30.2 Issue Detection History 220
30.3 Subjective Evaluation 220