Design Controls for the Medical Device Industry (2^nd Ed.)

The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money.

The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.

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

Practitioners in the medical device industry and graduate students in medical device design.

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.