This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations.
The book includes a review of the 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. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study.
This third edition:
- Examines new coverage of ISO 13485-2016 design control requirements
- Explores proven techniques and methods for compliance
- Contributes fresh templates for practical implementation
- Provides updated chapters with additional details for greater understanding and compliance
- Offers an easy to understand breakdown of design control requirements
- Reference to MDSAP design control requirements
Table of Contents
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. The FDA inspection technique. Appendix A: Design controls procedure. Appendix B: Design input document. Appendix C: Product claims sheet. Appendix D: Input/Output design traceability matrix. Appendix E: Project approval form. Appendix F: Design phase review meeting record. Appendix G: Risk analysis. Appendix H: Clinical evaluation report. Appendix I: Design transfer checklist. Appendix J: Design change form. Appendix K: Approval for sale form. Appendix L: Engineering change order form.
Marie B. Teixeira is the founder and principal consultant for QA/RA Compliance Connection, Inc. in Odessa, Florida. QARACC is a world-class consulting company providing expert management and guidance for its clients in all aspects of global quality management and regulatory affairs. Under her direction and guidance, her clients have received ISO 9001, ISO 13485, CE and MDSAP certification and obtained regulatory clearance for their medical devices internationally.
Before beginning this venture, she was Director of Quality Assurance and Regulatory Affairs at Bioderm, Inc., a start-up medical device company in the Tampa Bay Florida area where she designed, directed and implemented the policies and procedures that established this company’s compliance with global regulatory requirements.
Ms. Teixeira was also Quality Systems Manager for Regulatory Affairs at Smith & Nephew’s Wound Management Division in Largo, Florida. In addition to directing the planning, development and implementation of Smith & Nephew’s ISO 13485, FDA GMP, and MDD 93/42/EEC regulatory efforts, she implemented and directed the company’s internal audit program and management review system. It was her direction and guidance that allowed Smith & Nephew’s Wound Management Division to achieve ISO certification in less than a year, as well as their MDD certification one year later.
Ms. Teixeira began her career as a Quality Engineer for Raytheon, GTE Government Systems and Sparton Electronics. During her tenure at these companies she was responsible for establishing and implementing quality assurance programs and procedures, leading supplier and customer audits, developing and performing quality system and auditor training, initiating and managing corrective actions, and developing and implementing supplier certification programs. During her tenure at Sparton, she managed the company through its initial ISO certification and subsequent surveillance audits.
Marie Teixeira holds a BS in Industrial Engineering and Operations Research from the University of Massachusetts at Amherst. She is a member of the American Society for Quality. Ms. Teixeira is an ASQ Certified Quality Manager and Quality Engineer and an Exemplar Global Principal Auditor. Ms. Teixeira was also an active member of an international task force CEN/TC257/SC-DETG10 - whose objective was to standardize medical device nomenclature. Ms. Teixeira recently authored her third edition of the book titled "Design Controls for the Medical Device Industry". Ms. Teixeira has also published numerous quality system related CD-ROM training modules and related informational handbooks and has conducted numerous quality system training seminars.