Practical Design Control Implementation for Medical Devices

Justiniano, Jose; Gopalaswamy, Venky

ISBN 10: 1574911279 / ISBN 13: 9781574911275

Editore: CRC Press, 2003

Riguardo questo articolo

Codice articolo I-9781574911275

Dati bibliografici

• Titolo: Practical Design Control Implementation for Medical Devices
• Editore: CRC Press
• Data di pubblicazione: 2003
• Lingua: Inglese
• ISBN 10: 1574911279
• ISBN 13: 9781574911275
• Rilegatura: Rilegato
• Condizione: New

Descrizione articolo

Riassunto

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.

Informazioni sull?autore

Justiniano, Jose; Gopalaswamy, Venky