Global Medical Device Regulatory Strategy
viii Regulatory Affairs Professionals Society
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy. ...................................................187
Susumu Nozawa, RAC-EU, RAC-US, FRAPS
Chapter 16: Global Medical Device Marketing Strategy.....................................................................................207
Charles Tam, MBA, EP
Chapter 17: Regulatory Resources for Strategy Development. ............................................................................225
Gretchen E. Parker, PhD, CIP, RAC-US
Chapter 18: Global Postmarketing Regulatory Strategy. .....................................................................................249
Scott D. Dickerhoff, MBA, and Samata Veluvolu, MBA, RAC-US
Chapter 19: Borderline Regulation of Stem Cell Technologies: Therapies, Devices, and
Combination Products. ...................................................................................................................................275
Beat U. Steffen, MSc, MBA, RAC-Devices, FRAPS, and Andrea Lopes, PhD
Chapter 20: Patents and Intellectual Property......................................................................................................287
Stanley F. Chalvire, PharmD, JD, and Sean D. Detweiler, JD
Chapter 21: Software............................................................................................................................................299
Philip Desjardins, JD
Chapter 22: Cybersecurity....................................................................................................................................309
Colin Morgan, MS, CISSP, CISM
Index....................................................................................................................................................................321
Figures
Figure 1-1. Market Access External Stakeholders....................................................................................................2
Figure 1-2. PDP Internal Stakeholders and Collaborators......................................................................................3
Figure 1-3. Reimbursement for Medical Devices.....................................................................................................6
Figure 4-1. Comparison of Target Market Release Timelines................................................................................55
Figure 5-1. Basic Process Model. ...........................................................................................................................61
Figure 5-2. PDCA Cycle in Resource Management..............................................................................................61
Figure 5-3. Implementing an ISO 13485:2016 QMS............................................................................................65
Figure 5-4. Sample Schedule for QMS Implementation. ......................................................................................67
Figure 5-5. QMS Documentation Defining Responsibilities.................................................................................68
Figure 5-6. Typical QMS Document Hierarchy. ...................................................................................................69
Figure 5-7. Iterative PDCA Cycle. ........................................................................................................................70
Figure 5-8. ISO 17021 QMS Certification Cycle..................................................................................................72
Figure 5-9. Design Process.....................................................................................................................................77
Figure 6-1. Framework Developed by the Presidential Commission 1997 Report................................................85
Figure 6-2. NIST Cybersecurity Framework 2.0 Governance is Designed to be a Cross-Cutting Function
to Inform and be Infused throughout the Other Five Elements.12 ...................................................................86
Figure 6-3. NIST AI RMF Governance is Designed to be a Cross-Cutting Function to Inform and be
Infused throughout the Other Three Elements.................................................................................................87
Figure 6-4. High-Level Summary of Some Key Steps in Product Risk Management...........................................90
Figure 6-5. Comparison Example of Top-Down Hazard Analysis and Bottom-Up FMEA Tools. .....................92
Figure 7-2. Example of a Medical Device Label for Use in Multiple Regions.....................................................102
Figure 9-1. Strategy for Performing Animal Studies............................................................................................129
Figure 15-1. Document Hierarchy. ......................................................................................................................192
Figure 21-1. Rule 11 of Annex VIII of EU MDR ..............................................................................................306
Figure 22-1. Product Security Framework From the JSP.....................................................................................311
Figure 22-2. AAMI TIR57 and ISO14971 Crosswalk. .......................................................................................313
viii Regulatory Affairs Professionals Society
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy. ...................................................187
Susumu Nozawa, RAC-EU, RAC-US, FRAPS
Chapter 16: Global Medical Device Marketing Strategy.....................................................................................207
Charles Tam, MBA, EP
Chapter 17: Regulatory Resources for Strategy Development. ............................................................................225
Gretchen E. Parker, PhD, CIP, RAC-US
Chapter 18: Global Postmarketing Regulatory Strategy. .....................................................................................249
Scott D. Dickerhoff, MBA, and Samata Veluvolu, MBA, RAC-US
Chapter 19: Borderline Regulation of Stem Cell Technologies: Therapies, Devices, and
Combination Products. ...................................................................................................................................275
Beat U. Steffen, MSc, MBA, RAC-Devices, FRAPS, and Andrea Lopes, PhD
Chapter 20: Patents and Intellectual Property......................................................................................................287
Stanley F. Chalvire, PharmD, JD, and Sean D. Detweiler, JD
Chapter 21: Software............................................................................................................................................299
Philip Desjardins, JD
Chapter 22: Cybersecurity....................................................................................................................................309
Colin Morgan, MS, CISSP, CISM
Index....................................................................................................................................................................321
Figures
Figure 1-1. Market Access External Stakeholders....................................................................................................2
Figure 1-2. PDP Internal Stakeholders and Collaborators......................................................................................3
Figure 1-3. Reimbursement for Medical Devices.....................................................................................................6
Figure 4-1. Comparison of Target Market Release Timelines................................................................................55
Figure 5-1. Basic Process Model. ...........................................................................................................................61
Figure 5-2. PDCA Cycle in Resource Management..............................................................................................61
Figure 5-3. Implementing an ISO 13485:2016 QMS............................................................................................65
Figure 5-4. Sample Schedule for QMS Implementation. ......................................................................................67
Figure 5-5. QMS Documentation Defining Responsibilities.................................................................................68
Figure 5-6. Typical QMS Document Hierarchy. ...................................................................................................69
Figure 5-7. Iterative PDCA Cycle. ........................................................................................................................70
Figure 5-8. ISO 17021 QMS Certification Cycle..................................................................................................72
Figure 5-9. Design Process.....................................................................................................................................77
Figure 6-1. Framework Developed by the Presidential Commission 1997 Report................................................85
Figure 6-2. NIST Cybersecurity Framework 2.0 Governance is Designed to be a Cross-Cutting Function
to Inform and be Infused throughout the Other Five Elements.12 ...................................................................86
Figure 6-3. NIST AI RMF Governance is Designed to be a Cross-Cutting Function to Inform and be
Infused throughout the Other Three Elements.................................................................................................87
Figure 6-4. High-Level Summary of Some Key Steps in Product Risk Management...........................................90
Figure 6-5. Comparison Example of Top-Down Hazard Analysis and Bottom-Up FMEA Tools. .....................92
Figure 7-2. Example of a Medical Device Label for Use in Multiple Regions.....................................................102
Figure 9-1. Strategy for Performing Animal Studies............................................................................................129
Figure 15-1. Document Hierarchy. ......................................................................................................................192
Figure 21-1. Rule 11 of Annex VIII of EU MDR ..............................................................................................306
Figure 22-1. Product Security Framework From the JSP.....................................................................................311
Figure 22-2. AAMI TIR57 and ISO14971 Crosswalk. .......................................................................................313