Medical Device Validation Handbook
iv Regulatory Affairs Professionals Society (RAPS)
Chapter 13 Sample Sizes for Verification and Validation................................................................ 187
Steven Walfish
Chapter 14 Verification and Validation in Medical Device Computational Modeling and
Simulation. ...................................................................................................................201
Danny L. Levine, PhD, PE
Chapter 15 Additive (3D Printing) Manufacturing. .......................................................................213
John E. Lincoln
Chapter 16 Cybersecurity and Data Integrity. ................................................................................229
John E. Lincoln
Chapter 17 Validating the Medical Device Laser-Welding Process. ...............................................243
David W. Steinmeier and Lisa Schaller
Chapter 18 Start-up of Cleanrooms, Initially and After a Worst-Case Event. ...............................253
Jim Polarine and Beth Kroeger-Fahnestock
Index ......................................................................................................................................261
Figures
Figure 2-1. FDA Lifecycle. ...............................................................................................................10
Figure 2-2. Internet FTA Sample Format........................................................................................ 13
Figure 2-3. Possible Initial Descriptive Narrative.............................................................................. 15
Figure 2-4. Possible Hazard List Format. .........................................................................................16
Figure 2-5. Sample FTA................................................................................................................... 16
Figure 2-6. Sample Abbreviated Software FMECA......................................................................... 17
Figure 2-7. Fictitious Final Benefit-Risk Analysis/Statement. .........................................................18
Figure 2-8. Incorporating Risk in the V&V Protocol. ......................................................................19
Figure 3-1. Roles vs. Impact Matrix.................................................................................................. 22
Figure 3-2. Gap Analysis/Remediation Process Phases. ...................................................................23
Figure 3-3. Risk Level vs. Gap Size. .................................................................................................25
Figure 3-4. Cascading Effects of Standards Updates. .......................................................................28
Figure 3-5. Phase-gate Development Process. ..................................................................................30
Figure 3-6. Waterfall Methodology. .................................................................................................30
Figure 3-7. Critical Path Method. ....................................................................................................30
Figure 3-8. Hybrid Project Management Methodology Example ...................................................31
Figure 3-9. High-Level Gap Assessment Project Lifecycle .............................................................31
Figure 3-10. Simple Task Board View. ...............................................................................................31
Figure 3-11. Burndown Chart ...........................................................................................................31
Figure 3-12. Traditional vs. Iterative Planning in a Project Lifecycle .................................................32
Figure 4-1. Definition of a Test method, ASTM E1488-12(2023) .................................................34
Figure 4-2. Data Types vs. Resolution............................................................................................... 35
Figure 4-3. Process View of Test methods, Peel Test Example......................................................... 37
Figure 4-4. ISO 11607-1:2019, Section 4.4 Test Methods. ..............................................................41
Figure 4-5. TMV Waterfall Model (vs. FDA Design Control Guidance Waterfall). .......................44
Figure 4-6. Measurement Error, a Comparison of Two “Voices”....................................................... 45
Figure 4-7. Measurement Error and Decision-Making. ...................................................................46