viii
Chapter 13 Global Regulatory Processes.................................................................................... 183
Updated by Xianjun (Catherine) Chen, MS, RAC, Manuel Urena and Brian Young
Chapter 14 Global Regulatory Process—Third-Party Point of View. ........................................205
Updated by Gert Bos, MSc, PhD, FRAPS
Chapter 15 Use of Standards in Medical Device Global Regulatory Strategy............................217
Updated by Susumu Nozawa, RAC, FRAPS
Chapter 16 Global Medical Device Marketing Strategy............................................................ 241
Updated by Charles Tam, MBA
Chapter 17 Regulatory Resources for Strategy Development..................................................... 259
Updated by Gretchen E. Parker, PhD, RAC, CIP
Chapter 18 Global Postmarketing Regulatory Strategy. ............................................................287
Updated by Scott D. Dickerhoff
Chapter 19 Borderline Regulation of Stem Cell Technologies: Therapies, Devices and
Combination Products. ............................................................................................305
Updated by Anu Gaur, PhD, MBA, MSRA, RAC
Chapter 20 Patents and Intellectual Property............................................................................. 321
Updated by Stanley F. Chalvire, Sean D. Detweiler, David A. Fazzolare
and Lisa M. Warren
Chapter 21 Software. ..................................................................................................................335
Updated by Koen Cobbaert, MSEE, MSRM
Chapter 22 Cybersecurity. ..........................................................................................................361
Updated by Colin Morgan, CISSP, CISM, GPEN
Glossary ..................................................................................................................................373
Index ..................................................................................................................................389
Figures
Figure 1-1. Reimbursement for Medical Devices........................................................................... 7
Figure 4-1. Comparison of Target Market Release Timelines ....................................................56
Figure 5-1. Basic Process Model................................................................................................... 61
Figure 5-2. PDCA Cycle in Resource Management. ...................................................................62
Figure 5-3. Mandatory Procedures and Documents for ISO 13485:2003. ..................................69
Figure 5-4. Implementing an ISO 13485:2016 QMS. .................................................................71
Figure 5-5. Sample Schedule for QMS Implementation. .............................................................73
Figure 5-6. QMS Documentation Defining Responsibilities....................................................... 74
Figure 5-7. Typical QMS Document Hierarchy. .........................................................................75
Figure 5-8. Iterative PDCA Cycle................................................................................................ 77
Figure 5-9. ISO 17021 QMS Certification Cycle........................................................................ 79
Chapter 13 Global Regulatory Processes.................................................................................... 183
Updated by Xianjun (Catherine) Chen, MS, RAC, Manuel Urena and Brian Young
Chapter 14 Global Regulatory Process—Third-Party Point of View. ........................................205
Updated by Gert Bos, MSc, PhD, FRAPS
Chapter 15 Use of Standards in Medical Device Global Regulatory Strategy............................217
Updated by Susumu Nozawa, RAC, FRAPS
Chapter 16 Global Medical Device Marketing Strategy............................................................ 241
Updated by Charles Tam, MBA
Chapter 17 Regulatory Resources for Strategy Development..................................................... 259
Updated by Gretchen E. Parker, PhD, RAC, CIP
Chapter 18 Global Postmarketing Regulatory Strategy. ............................................................287
Updated by Scott D. Dickerhoff
Chapter 19 Borderline Regulation of Stem Cell Technologies: Therapies, Devices and
Combination Products. ............................................................................................305
Updated by Anu Gaur, PhD, MBA, MSRA, RAC
Chapter 20 Patents and Intellectual Property............................................................................. 321
Updated by Stanley F. Chalvire, Sean D. Detweiler, David A. Fazzolare
and Lisa M. Warren
Chapter 21 Software. ..................................................................................................................335
Updated by Koen Cobbaert, MSEE, MSRM
Chapter 22 Cybersecurity. ..........................................................................................................361
Updated by Colin Morgan, CISSP, CISM, GPEN
Glossary ..................................................................................................................................373
Index ..................................................................................................................................389
Figures
Figure 1-1. Reimbursement for Medical Devices........................................................................... 7
Figure 4-1. Comparison of Target Market Release Timelines ....................................................56
Figure 5-1. Basic Process Model................................................................................................... 61
Figure 5-2. PDCA Cycle in Resource Management. ...................................................................62
Figure 5-3. Mandatory Procedures and Documents for ISO 13485:2003. ..................................69
Figure 5-4. Implementing an ISO 13485:2016 QMS. .................................................................71
Figure 5-5. Sample Schedule for QMS Implementation. .............................................................73
Figure 5-6. QMS Documentation Defining Responsibilities....................................................... 74
Figure 5-7. Typical QMS Document Hierarchy. .........................................................................75
Figure 5-8. Iterative PDCA Cycle................................................................................................ 77
Figure 5-9. ISO 17021 QMS Certification Cycle........................................................................ 79