Design Controls for the Medical Device Industry - Marie B. Teixeira

Design Controls for the Medical Device Industry

Buch | Hardcover
205 Seiten
2013 | 2nd New edition
Crc Press Inc (Verlag)
978-1-4665-0354-0 (ISBN)
218,20 inkl. MwSt
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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.

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

Erscheint lt. Verlag 24.12.2013
Zusatzinfo 13 Tables, black and white; 9 Illustrations, black and white
Verlagsort Bosa Roca
Sprache englisch
Maße 156 x 235 mm
Gewicht 486 g
Themenwelt Medizin / Pharmazie
Technik Maschinenbau
Technik Medizintechnik
Technik Umwelttechnik / Biotechnologie
ISBN-10 1-4665-0354-8 / 1466503548
ISBN-13 978-1-4665-0354-0 / 9781466503540
Zustand Neuware
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