Page 12 - Safety Risk Management for Medical Devices

Contents xi

31. Risk Management and Product Development Process 221
31.1 Identification of Essential Design Outputs 222
31.2 Lifecycle Relevance of Risk Management 224

32. Axioms 227

33. Special Topics 229
33.1 The Conundrum 229
33.2 Cassandras 230
33.3 Personal Liability 230
33.4 Risk Management for Combination Medical Devices 231

34. Critical Thinking and Risk Management 233

35. Advice and Wisdom 235

Appendix A: Glossary 237
Appendix B: Templates 239
Appendix C: Example Device—Vivio 265
Appendix D: NBRG Consensus Paper 377
References 391
Index 393