Design controls for the medical device industry

✍ Scribed by Marie B Teixeira

• Publisher: Taylor & Francis
• Year: 2013
• Tongue: English
• Leaves: 196
• Category: Library

✦ Synopsis

''Design control is a key element of a company's quality management system and is mandated by the U.S. FDA's Quality System Regulation under article 820.30 for most medical devices. Medical device companies wishing to comply with ISO 13485 to meet international requirements are also subject to design control requirements. This second edition of a bestselling book expands and updates all chapters with detail on current design control requirements, more examples, and further explanation and clarification of the requirements. The book also addresses device risk and classification, and covers risk management in its own chapter. Appendices have also been revised''--Provided by publisher. Read more...

✦ Table of Contents

Content: 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
Abstract: ''Design control is a key element of a company's quality management system and is mandated by the U.S. FDA's Quality System Regulation under article 820.30 for most medical devices. Medical device companies wishing to comply with ISO 13485 to meet international requirements are also subject to design control requirements. This second edition of a bestselling book expands and updates all chapters with detail on current design control requirements, more examples, and further explanation and clarification of the requirements. The book also addresses device risk and classification, and covers risk management in its own chapter. Appendices have also been revised''--Provided by publisher