Design Controls for the Medical Device Industry

Marie B. Teixeira is founder and principal consultant for QA/RA Compliance Connection, Inc., Odessa, Florida, USA. She holds a BS from University of Massachusetts Amherst, USA and is an American Society for Quality member, ASQ-certified quality manager and engineer, and RABQSA principle auditor. Previously she served as quality engineer at Raytheon, Norwood, Massachusetts, USA; GTE Government Systems, Needham Heights, Massachusetts, USA; and Sparton Electronics, Brooksville, Florida, USA; as well as director of quality assurance and regulatory affairs at Bioderm, Inc., Tampa Bay, Florida, USA and quality systems manager for regulatory affairs at Smith & Nephew, Largo, Florida, USA.

Preface


Author Biography


Introduction


Device Classification


Overview of Design Controls


Design and Development Planning


Design Inputs Part I


Design Inputs Part II


Design Outputs


Design Review


Design Verification


Risk Management


Design Validation


Biocompatibility


Design Transfer


Design Change


Design History File


Quality System Inspection Technique


References


Appendix A – Design Controls Procedure


Appendix B – Product Performance Specification


Appendix C – Product Claims Sheet


Appendix D – Design Input/Output Matrix


Appendix E – Project Approval Form


Appendix F – Design Review Meeting Record Template


Appendix G – Risk Management Plan Template


Appendix H – Clinical Evaluation Report Template


Appendix I – Design Transfer Checklist


Appendix J – Design Change Form Template


Appendix K – Approval for Sale Template


Index