The Medical Device Validation Handbook
iii
Table of Contents
Chapter 1 Regulatory Basics of Process and Design Validation. .......................................................1
Robert Falcone, Ph.D., FRAPS, FTOPRA
Chapter 2 Risk-Based Verification and Validation. ...........................................................................7
John E. Lincoln
Chapter 3 Gap Assessments for Medical Devices. ..........................................................................21
Brett Hofman, BS, MBA, Courtney Divine, BS, CPP, CSSGB, Heather Valley, MS,
RAC-Global, and Timothy Wech, MSE, PE
Chapter 4 Test Method Validation and How it is Used for Medical Devices and Packaging. ........33
Brian K. Farison, Dylan Stover, and John E. Lincoln
Chapter 5 Design of Experiments................................................................................................... 57
Anthony Carra
Chapter 6 Sterilization Validation Principles. .................................................................................77
Gerry O’Dell
Chapter 7 Six Sigma Concepts in Validation Studies for Medical Device Packaging. ....................95
Brian K. Farison and Rod Patch
Chapter 8 Medical Packaging Validation. .....................................................................................117
David DiVaccaro
Chapter 9 Cleaning Validations of Medical Products.................................................................... 125
Steven G. Richter, PhD
Chapter 10 Software Validation for Life Sciences........................................................................... 135
Wes Bloemker
Chapter 11 FDA Unique Device Identification Verification and Validation................................... 161
Jonathan C. Bretz and Jay Crowley
Chapter 12 Equipment Validation.................................................................................................. 173
John E. Lincoln
iii
Table of Contents
Chapter 1 Regulatory Basics of Process and Design Validation. .......................................................1
Robert Falcone, Ph.D., FRAPS, FTOPRA
Chapter 2 Risk-Based Verification and Validation. ...........................................................................7
John E. Lincoln
Chapter 3 Gap Assessments for Medical Devices. ..........................................................................21
Brett Hofman, BS, MBA, Courtney Divine, BS, CPP, CSSGB, Heather Valley, MS,
RAC-Global, and Timothy Wech, MSE, PE
Chapter 4 Test Method Validation and How it is Used for Medical Devices and Packaging. ........33
Brian K. Farison, Dylan Stover, and John E. Lincoln
Chapter 5 Design of Experiments................................................................................................... 57
Anthony Carra
Chapter 6 Sterilization Validation Principles. .................................................................................77
Gerry O’Dell
Chapter 7 Six Sigma Concepts in Validation Studies for Medical Device Packaging. ....................95
Brian K. Farison and Rod Patch
Chapter 8 Medical Packaging Validation. .....................................................................................117
David DiVaccaro
Chapter 9 Cleaning Validations of Medical Products.................................................................... 125
Steven G. Richter, PhD
Chapter 10 Software Validation for Life Sciences........................................................................... 135
Wes Bloemker
Chapter 11 FDA Unique Device Identification Verification and Validation................................... 161
Jonathan C. Bretz and Jay Crowley
Chapter 12 Equipment Validation.................................................................................................. 173
John E. Lincoln