Global Medical Device Regulatory Strategy
vii Regulatory Affairs Professionals Society
Contents
Foreword. ................................................................................................................................................................iii
Author Acknowledgments.......................................................................................................................................v
Chapter 1: Driving Successful Commercial Product Launches................................................................................1
Flora Sandra Siami, MPH
Chapter 2: Elements to Consider When Developing a Global Regulatory Strategy. ............................................13
Thomas Hutchinson, MS, CQA, CMDA, CMQ/OE, RAC-US, FRAPS
Chapter 3: Core Development Teams. ...................................................................................................................19
Anuja Yardi, MS-RA, MSPM, MPharm, RAC–US
Chapter 4: Components of Regulatory Strategy – The Basics................................................................................47
Melissa Walker, MS, RAC-US, FRAPS
Chapter 5: Setting up a Quality Management System...........................................................................................59
Susumu Nozawa, RAC-EU, RAC-US, FRAPS
Chapter 6: Risk Management Strategies for Device Design and Development Processes ....................................83
Shannon Hoste, MSM, MSSE
Chapter 7: Global Medical Device Labeling Strategies. ........................................................................................99
Foram Shukla, PharmD, MS-RA
Chapter 8: Manufacturing....................................................................................................................................115
Andrea Armando, MS
Chapter 9: Nonclinical Laboratory Testing..........................................................................................................123
Dorota Grabowska, PhD, and Peter A. Takes, PhD, RAC-US, FRAPS
Chapter 10: Global Medical Device Clinical Strategy. ........................................................................................135
Dawn N. Norman, MS
Chapter 11: In Vitro Diagnostic Medical Devices. ..............................................................................................143
Jocelyn Jennings, MSRA, RAC-Devices, RAC-Drugs, RAC-US, RAC-Global, FRAPS
Chapter 12: Combination Products......................................................................................................................155
Allyson B. Mullen, JD
Chapter 13: Global Regulatory Processes.............................................................................................................165
Manuel Urena, Xianjun Chen, MS and Brian Young
Chapter 14: Global Regulatory Process – Third-Party Point of View. .................................................................179
Gert Bos, PhD, MSc, FRAPS
vii Regulatory Affairs Professionals Society
Contents
Foreword. ................................................................................................................................................................iii
Author Acknowledgments.......................................................................................................................................v
Chapter 1: Driving Successful Commercial Product Launches................................................................................1
Flora Sandra Siami, MPH
Chapter 2: Elements to Consider When Developing a Global Regulatory Strategy. ............................................13
Thomas Hutchinson, MS, CQA, CMDA, CMQ/OE, RAC-US, FRAPS
Chapter 3: Core Development Teams. ...................................................................................................................19
Anuja Yardi, MS-RA, MSPM, MPharm, RAC–US
Chapter 4: Components of Regulatory Strategy – The Basics................................................................................47
Melissa Walker, MS, RAC-US, FRAPS
Chapter 5: Setting up a Quality Management System...........................................................................................59
Susumu Nozawa, RAC-EU, RAC-US, FRAPS
Chapter 6: Risk Management Strategies for Device Design and Development Processes ....................................83
Shannon Hoste, MSM, MSSE
Chapter 7: Global Medical Device Labeling Strategies. ........................................................................................99
Foram Shukla, PharmD, MS-RA
Chapter 8: Manufacturing....................................................................................................................................115
Andrea Armando, MS
Chapter 9: Nonclinical Laboratory Testing..........................................................................................................123
Dorota Grabowska, PhD, and Peter A. Takes, PhD, RAC-US, FRAPS
Chapter 10: Global Medical Device Clinical Strategy. ........................................................................................135
Dawn N. Norman, MS
Chapter 11: In Vitro Diagnostic Medical Devices. ..............................................................................................143
Jocelyn Jennings, MSRA, RAC-Devices, RAC-Drugs, RAC-US, RAC-Global, FRAPS
Chapter 12: Combination Products......................................................................................................................155
Allyson B. Mullen, JD
Chapter 13: Global Regulatory Processes.............................................................................................................165
Manuel Urena, Xianjun Chen, MS and Brian Young
Chapter 14: Global Regulatory Process – Third-Party Point of View. .................................................................179
Gert Bos, PhD, MSc, FRAPS