Design Controls for the Medical Device Industry: 2nd Edition (Paperback) book cover

Design Controls for the Medical Device Industry

2nd Edition

By Marie B. Teixeira, Marie B. Teixeira

CRC Press

205 pages | 9 B/W Illus.

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Description

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 author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with:

  • New coverage of ISO 9001 and 13485 design control requirements
  • More real-world examples from the medical device industry
  • Additional detail for greater understanding and clarity
  • Fresh templates for practical implementation
  • Extensive references for further study

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.

Table of Contents

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

About the Authors

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.

Subject Categories

BISAC Subject Codes/Headings:
MED000000
MEDICAL / General
MED009000
MEDICAL / Biotechnology
TEC021000
TECHNOLOGY & ENGINEERING / Material Science