Jose Justiniano, Venky Gopalaswamy

Practical Design Control Implementation for Medical Devices (eBook, PDF)

• Format: PDF

Produktbeschreibung

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.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 232
• Erscheinungstermin: 12. März 2003
• Englisch
• ISBN-13: 9780203010716
• Artikelnr.: 38165249

Autorenporträt

Justiniano, Jose; Gopalaswamy, Venky

Inhaltsangabe

PART ONE Practical Design Control Implementation
PART TWO Medical Device Reliability
Conclusion
Acronyms and Definitions
References