Practical Design Control Implementation for Medical Devices

Jose Justiniano, Venky Gopalaswamy (Autoren)

Buch | Hardcover

230 Seiten

2003
Crc Press Inc (Verlag)
978-1-57491-127-5 (ISBN)

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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.

Justiniano, Jose; Gopalaswamy, Venky

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

Erscheint lt. Verlag	12.3.2003
Zusatzinfo	43 Tables, black and white; 34 Illustrations, black and white
Verlagsort	Bosa Roca
Sprache	englisch
Maße	178 x 254 mm
Gewicht	616 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
Themenwelt	Technik ► Medizintechnik
ISBN-10	1-57491-127-9 / 1574911279
ISBN-13	978-1-57491-127-5 / 9781574911275
Zustand	Neuware