Design Controls for the Medical Device Industry
Routledge (Verlag)
978-1-138-07371-5 (ISBN)
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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
| Erscheinungsdatum | 23.04.2017 |
|---|---|
| Zusatzinfo | 13 Tables, black and white; 9 Illustrations, black and white |
| Verlagsort | London |
| Sprache | englisch |
| Maße | 156 x 235 mm |
| Gewicht | 380 g |
| Themenwelt | Medizin / Pharmazie ► Physiotherapie / Ergotherapie ► Orthopädie |
| Technik ► Maschinenbau | |
| Technik ► Medizintechnik | |
| Technik ► Umwelttechnik / Biotechnologie | |
| ISBN-10 | 1-138-07371-7 / 1138073717 |
| ISBN-13 | 978-1-138-07371-5 / 9781138073715 |
| Zustand | Neuware |
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