Full 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 requirementsMore real-world examples from the medical device industryAdditional detail for greater understanding and clarityFresh templates for practical implementationExtensive references for further studyThe 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.
Contents
PrefaceAuthor BiographyIntroductionDevice ClassificationOverview of Design ControlsDesign and Development PlanningDesign Inputs Part IDesign Inputs Part IIDesign OutputsDesign ReviewDesign VerificationRisk ManagementDesign ValidationBiocompatibilityDesign TransferDesign ChangeDesign History FileQuality System Inspection TechniqueReferencesAppendix 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
