ix
Figure 5-10. Design Process. ..........................................................................................................85
Figure 6-1. FDA’s View on Managing Pre- and Postmarket Product Risks.............................. 101
Figure 6-2. FDA’s Role in Medical Product Risk Management (Rx Products). ........................102
Figure 6-3. Framework for Environmental Health Risk Management...................................... 103
Figure 7-1. Example of Label Incorporating a UDI ...................................................................114
Figure 7-2. Example of a Medical Device Label for Use in Multiple Regions........................... 115
Figure 9-1. Strategy for Performing Animal Studies. ................................................................143
Figure 13-1. Regulatory Submission Process Flow...................................................................... 183
Figure 13-2. Data Integrity Verification Process Outline............................................................. 189
Figure 15-1. Document Hierarchy. ..............................................................................................223
Figure 16-1. Estimated Cost of Medical Device Regulatory Approval by Country. ...................247
Figure 21-1. Details of Scrum Methodology ...............................................................................347
Figure 22-1. Product Security Framework From the JSP............................................................. 363
Figure 22-2. AAMI TIR57 and ISO14971 Crosswalk................................................................ 366
Tables
Table 1-1. Main Types of US Reimbursement Coding Systems ..................................................9
Table 1-2. Types of Economic Evaluations. ................................................................................11
Table 3-1. Example—Development Phases. ...............................................................................25
Table 3-2. Regulatory Pathway Assessment Elements................................................................ 28
Table 3-3. Regulatory Strategy and Plan Elements. ...................................................................37
Table 3-4. Ebb and Flow of Core Team Member Involvement. .................................................43
Table 4-1. Simplified Global Regulatory Strategy Element Table.............................................. 48
Table 4-2. Simplified Example of the Expanded Element Table................................................ 54
Table 4-3. Regulatory Submission Requirements. ......................................................................55
Table 4-4. Summary of Regulatory Risks. ..................................................................................57
Table 5-1. Key Differences Between ISO 9001 and ISO 13485................................................ 59
Table 5-2. Similarities Between ISO 9001 and ISO 13485........................................................ 60
Table 5-3. Comparison of ISO 13485:2003 and ISO 13485:2016. ............................................64
Table 5-4. Applicability of ISO 13485 in Various Global Jurisdictions...................................... 70
Table 5-5. Benefits and Barriers to Certification. .......................................................................78
Table 5-6. Certification Body QMS Assessment Objectives, Scope and Criteria. .....................80
Table 5-7. Audit Duration for Medical Device ISO 13485 Audits Based on Staff Numbers. ...80
Table 5-8. Factors That May Increase or Reduce Audit Durations............................................. 81
Table 6-1. Risk Mitigation Strategies. ........................................................................................95
Table 7-1. Key Medical Device Labeling Regulations in the EU MDR.................................. 112
Table 7-2. Key Medical Device Labeling Regulations in the US: Code of Federal
Regulation................................................................................................................ 113
Table 7-3. ISO FDIS 20417: Medical Devices—Information to be Supplied by the
Manufacturer ...........................................................................................................116
Table 9-1. The Universal Elements of GLP .............................................................................137
Table 9-2. Examples of GLP Violations From FDA Warning Letters. ...................................138
Table 9-3. Sources of Device Risk............................................................................................. 139
Table 9-4. Biocompatibility Tests.............................................................................................. 140
Table 9-5. Medical Device Classification Based on the Nature of Body Contact and
Contact Duration......................................................................................................141
Table 9-6. Basic Animal Study Protocol Elements. ..................................................................142
Table 9-7. Animal Models for In Vivo Medical Device Assessment........................................ 144
Figure 5-10. Design Process. ..........................................................................................................85
Figure 6-1. FDA’s View on Managing Pre- and Postmarket Product Risks.............................. 101
Figure 6-2. FDA’s Role in Medical Product Risk Management (Rx Products). ........................102
Figure 6-3. Framework for Environmental Health Risk Management...................................... 103
Figure 7-1. Example of Label Incorporating a UDI ...................................................................114
Figure 7-2. Example of a Medical Device Label for Use in Multiple Regions........................... 115
Figure 9-1. Strategy for Performing Animal Studies. ................................................................143
Figure 13-1. Regulatory Submission Process Flow...................................................................... 183
Figure 13-2. Data Integrity Verification Process Outline............................................................. 189
Figure 15-1. Document Hierarchy. ..............................................................................................223
Figure 16-1. Estimated Cost of Medical Device Regulatory Approval by Country. ...................247
Figure 21-1. Details of Scrum Methodology ...............................................................................347
Figure 22-1. Product Security Framework From the JSP............................................................. 363
Figure 22-2. AAMI TIR57 and ISO14971 Crosswalk................................................................ 366
Tables
Table 1-1. Main Types of US Reimbursement Coding Systems ..................................................9
Table 1-2. Types of Economic Evaluations. ................................................................................11
Table 3-1. Example—Development Phases. ...............................................................................25
Table 3-2. Regulatory Pathway Assessment Elements................................................................ 28
Table 3-3. Regulatory Strategy and Plan Elements. ...................................................................37
Table 3-4. Ebb and Flow of Core Team Member Involvement. .................................................43
Table 4-1. Simplified Global Regulatory Strategy Element Table.............................................. 48
Table 4-2. Simplified Example of the Expanded Element Table................................................ 54
Table 4-3. Regulatory Submission Requirements. ......................................................................55
Table 4-4. Summary of Regulatory Risks. ..................................................................................57
Table 5-1. Key Differences Between ISO 9001 and ISO 13485................................................ 59
Table 5-2. Similarities Between ISO 9001 and ISO 13485........................................................ 60
Table 5-3. Comparison of ISO 13485:2003 and ISO 13485:2016. ............................................64
Table 5-4. Applicability of ISO 13485 in Various Global Jurisdictions...................................... 70
Table 5-5. Benefits and Barriers to Certification. .......................................................................78
Table 5-6. Certification Body QMS Assessment Objectives, Scope and Criteria. .....................80
Table 5-7. Audit Duration for Medical Device ISO 13485 Audits Based on Staff Numbers. ...80
Table 5-8. Factors That May Increase or Reduce Audit Durations............................................. 81
Table 6-1. Risk Mitigation Strategies. ........................................................................................95
Table 7-1. Key Medical Device Labeling Regulations in the EU MDR.................................. 112
Table 7-2. Key Medical Device Labeling Regulations in the US: Code of Federal
Regulation................................................................................................................ 113
Table 7-3. ISO FDIS 20417: Medical Devices—Information to be Supplied by the
Manufacturer ...........................................................................................................116
Table 9-1. The Universal Elements of GLP .............................................................................137
Table 9-2. Examples of GLP Violations From FDA Warning Letters. ...................................138
Table 9-3. Sources of Device Risk............................................................................................. 139
Table 9-4. Biocompatibility Tests.............................................................................................. 140
Table 9-5. Medical Device Classification Based on the Nature of Body Contact and
Contact Duration......................................................................................................141
Table 9-6. Basic Animal Study Protocol Elements. ..................................................................142
Table 9-7. Animal Models for In Vivo Medical Device Assessment........................................ 144