Design controls for the medical device industry / Marie B. Teixeira.

By: Teixeira, Marie B, 1965-Material type: TextTextLanguage: English Copyright date: Boca Raton : CRC Press , 2014Edition: Second editionDescription: xii, 193 pages ; illustrations ; 25 cmISBN: 9781466503540 (hardcover : alk. paper)Other title: Medical device industrySubject(s): Equipment Design -- standards -- United States | Diseño de equipo -- Estándares -- Estados Unidos | Equipment and Supplies -- standards -- United States | Oil industry -- standards -- United States | Quality Control -- United StatesDDC classification: 610.28
Partial contents:
1. Introduction -- 2. Device classification -- 3. Overview of design controls -- 4. Design and development planning -- 5. Design inputs : part I -- 6. Design inputs : part II -- 7. Design outputs -- 8. Design review -- 9. Design verification -- 10. Risk management -- 11. Design validation -- 12. Biocompatibility -- 13. Design transfer -- 14. Design change -- 15. Design history file -- 16. The FDA inspection technique.
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.
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Item type Current library Call number Copy number Status Date due Barcode Item holds
Libro académico Libro académico Biblioteca del Campus
610.28 T266 2014 (Browse shelf (Opens below)) Ej. 1 Available 000921
Total holds: 0

Includes index.

Includes bibliographical references (pages 181-182).

1. Introduction -- 2. Device classification -- 3. Overview of design controls -- 4. Design and development planning -- 5. Design inputs : part I -- 6. Design inputs : part II -- 7. Design outputs -- 8. Design review -- 9. Design verification -- 10. Risk management -- 11. Design validation -- 12. Biocompatibility -- 13. Design transfer -- 14. Design change -- 15. Design history file -- 16. The FDA inspection technique.

"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.

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