vii
Table of Contents
Section I: General Information
Chapter 1: Medical Devices: A History. ...........................................................................................................................................................1
Elizabeth Trautman Hillsley, MS Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS Isabella Schmitt, MBA, RAC-Devices Kimberly A. Trautman, MS
and Jocelyn Zhu, MBA
Chapter 2: Overview of Medical Device Policy and Regulation. ....................................................................................................................19
Khyati Jagdish Ashtekar, MS Lauren E. Jackson Tina O’Brien, MSc, RAC-US, RCC-MDR Sharon Perez, PhD Karen Zhou, JD, MS, RAC-Devices, RAC-Global and
Jocelyn Zhu, MBA
Chapter 3: Key Regulatory Agencies and Authorities ....................................................................................................................................47
Elizabeth Goldstein, RAC-US Daniele Lioi, PRRC and Jocelyn Zhu, MBA
Chapter 4: Standards Organizations. ..............................................................................................................................................................61
Richie Christian, MSc, RAC-Devices
Chapter 5: Device Classification. ....................................................................................................................................................................75
Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS
Section II: Device Design &Development
Chapter 6: Quality Systems Including Inspections and Audits....................................................................................................................... 85
Helen Hwang Chow, PhD, RAC-US Elizabeth Trautman Hillsley, MS John Rossman, MBEE, PMP Kimberly A. Trautman, MS and Liang Xu, MEng, RAC-Devices,
RCC-MDR, RCC-IVDR, PMP
Chapter 7: Risk Management. ........................................................................................................................................................................99
Karen Fan, MSc, RAC-CAN, RAC-EU, RAC-US, PEng, PMP and Rutvik Patel, MS
Chapter 8: Design Controls. .........................................................................................................................................................................113
Carrie M Kuehn, DLP, MA, MPH, RAC-US
Chapter 9: Lifecycle Management. ...............................................................................................................................................................119
Mark Durivage, MS, RAC-Global and Melissa R. O’Connor, MS, RAC-Devices, FRAPS
Chapter 10: Labeling..................................................................................................................................................................................... 123
Katelin Henninger, MS, RAC-Devices, RCC-MDR
Chapter 11: Human Factors Engineering.................................................................................................................................................... 137
Huiyang Li, PhD Ricky (Ruiqi) Ma, PhD and Xueke Wang, PhD, RAC-Devices
Section III: Nonclinical Testing
Chapter 12: Overview/Role of Nonclinical Testing. .....................................................................................................................................145
Richard A. Vincins, RAC-Devices
Chapter 13: Sterilization. ..............................................................................................................................................................................153
Gerry O’Dell, MS
Table of Contents
Section I: General Information
Chapter 1: Medical Devices: A History. ...........................................................................................................................................................1
Elizabeth Trautman Hillsley, MS Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS Isabella Schmitt, MBA, RAC-Devices Kimberly A. Trautman, MS
and Jocelyn Zhu, MBA
Chapter 2: Overview of Medical Device Policy and Regulation. ....................................................................................................................19
Khyati Jagdish Ashtekar, MS Lauren E. Jackson Tina O’Brien, MSc, RAC-US, RCC-MDR Sharon Perez, PhD Karen Zhou, JD, MS, RAC-Devices, RAC-Global and
Jocelyn Zhu, MBA
Chapter 3: Key Regulatory Agencies and Authorities ....................................................................................................................................47
Elizabeth Goldstein, RAC-US Daniele Lioi, PRRC and Jocelyn Zhu, MBA
Chapter 4: Standards Organizations. ..............................................................................................................................................................61
Richie Christian, MSc, RAC-Devices
Chapter 5: Device Classification. ....................................................................................................................................................................75
Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS
Section II: Device Design &Development
Chapter 6: Quality Systems Including Inspections and Audits....................................................................................................................... 85
Helen Hwang Chow, PhD, RAC-US Elizabeth Trautman Hillsley, MS John Rossman, MBEE, PMP Kimberly A. Trautman, MS and Liang Xu, MEng, RAC-Devices,
RCC-MDR, RCC-IVDR, PMP
Chapter 7: Risk Management. ........................................................................................................................................................................99
Karen Fan, MSc, RAC-CAN, RAC-EU, RAC-US, PEng, PMP and Rutvik Patel, MS
Chapter 8: Design Controls. .........................................................................................................................................................................113
Carrie M Kuehn, DLP, MA, MPH, RAC-US
Chapter 9: Lifecycle Management. ...............................................................................................................................................................119
Mark Durivage, MS, RAC-Global and Melissa R. O’Connor, MS, RAC-Devices, FRAPS
Chapter 10: Labeling..................................................................................................................................................................................... 123
Katelin Henninger, MS, RAC-Devices, RCC-MDR
Chapter 11: Human Factors Engineering.................................................................................................................................................... 137
Huiyang Li, PhD Ricky (Ruiqi) Ma, PhD and Xueke Wang, PhD, RAC-Devices
Section III: Nonclinical Testing
Chapter 12: Overview/Role of Nonclinical Testing. .....................................................................................................................................145
Richard A. Vincins, RAC-Devices
Chapter 13: Sterilization. ..............................................................................................................................................................................153
Gerry O’Dell, MS