Design controls for the medical device industry / Marie B. Teixeira.
Tipo de material: TextoIdioma: Inglés Detalles de publicación: Boca Raton : CRC Press, c2014Edición: 2nd edDescripción: xii, 193 p. ; ill. ; 25 cmISBN:- 9781466503540 (hardcover : alk. paper)
- Medical device industry
- 610.28 23
Tipo de ítem | Biblioteca actual | Signatura | Copia número | Estado | Fecha de vencimiento | Código de barras | Reserva de ítems | |
---|---|---|---|---|---|---|---|---|
Colección general | Biblioteca Yachay Tech | 610.28 T266 2014 (Navegar estantería(Abre debajo)) | Ej. 1 | Disponible | 000921 |
Includes bibliographical references (pages 181-182) and index.
"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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