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Contents
Chapter 1 Driving Successful Commercial Product Launches.................................................... 1
Updated by Michael Reiner, MBA
Chapter 2 Development and Implementation of Regulatory Strategies for Medical Devices.... 15
Updated by Thomas R. Hutchinson, MS, RAC, FRAPS
Chapter 3 Core Development Teams.......................................................................................... 21
Updated by Pamela J. Weagraff, MBA
Chapter 4 Components of Regulatory Strategy—The Basics. ....................................................47
Updated by Melissa Walker, MS, RAC, FRAPS
Chapter 5 Setting up a Quality Management System. ...............................................................59
Updated by Abhishek Harde, PMP, RAC
Chapter 6 Risk Management Strategies for Device Design and Development Processes.......... 93
Updated by Thomas McNamara, MSE, RAC
Chapter 7 Global Medical Device Labeling Strategies. ............................................................111
Updated by Cathleen O’Connell, RPh, PhD
Chapter 8 Manufacturing. ........................................................................................................127
Updated by Andrea Armando, RAC
Chapter 9 Nonclinical Laboratory Testing. ..............................................................................135
Updated by Dorota Grabowska, PhD and Peter A. Takes, PhD, RAC, FRAPS
Chapter 10 Global Medical Device Clinical Strategy. ...............................................................149
Updated by Dawn Norman, MS
Chapter 11 In Vitro Diagnostic Medical Devices. .....................................................................157
Updated by Jocelyn Jennings, MS, RAC
Chapter 12 Combination Products. ............................................................................................171
Updated by Allyson B. Mullen and Jeffrey N. Gibbs
Contents
Chapter 1 Driving Successful Commercial Product Launches.................................................... 1
Updated by Michael Reiner, MBA
Chapter 2 Development and Implementation of Regulatory Strategies for Medical Devices.... 15
Updated by Thomas R. Hutchinson, MS, RAC, FRAPS
Chapter 3 Core Development Teams.......................................................................................... 21
Updated by Pamela J. Weagraff, MBA
Chapter 4 Components of Regulatory Strategy—The Basics. ....................................................47
Updated by Melissa Walker, MS, RAC, FRAPS
Chapter 5 Setting up a Quality Management System. ...............................................................59
Updated by Abhishek Harde, PMP, RAC
Chapter 6 Risk Management Strategies for Device Design and Development Processes.......... 93
Updated by Thomas McNamara, MSE, RAC
Chapter 7 Global Medical Device Labeling Strategies. ............................................................111
Updated by Cathleen O’Connell, RPh, PhD
Chapter 8 Manufacturing. ........................................................................................................127
Updated by Andrea Armando, RAC
Chapter 9 Nonclinical Laboratory Testing. ..............................................................................135
Updated by Dorota Grabowska, PhD and Peter A. Takes, PhD, RAC, FRAPS
Chapter 10 Global Medical Device Clinical Strategy. ...............................................................149
Updated by Dawn Norman, MS
Chapter 11 In Vitro Diagnostic Medical Devices. .....................................................................157
Updated by Jocelyn Jennings, MS, RAC
Chapter 12 Combination Products. ............................................................................................171
Updated by Allyson B. Mullen and Jeffrey N. Gibbs