205 pages | 9 B/W Illus.
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:
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.
Overview of Design Controls
Design and Development Planning
Design Inputs Part I
Design Inputs Part II
Design History File
Quality System Inspection Technique
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