Practical Design Control Implementation for Medical Devices

Jose M Justiniano Venky Gopalaswamy Jose Justiniano

ISBN 10: 1574911279 / ISBN 13: 9781574911275

Verlag: Taylor & Francis Group, 2003

Beschreibung

pp. v + 223. Bestandsnummer des Verkäufers 262077937

Bibliografische Details

Titel: Practical Design Control Implementation for ...

Verlag: Taylor & Francis Group

Erscheinungsdatum: 2003

Einband: Hardcover

Zustand: New

Über diesen Titel

Reseña del editor:

Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.