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Beschreibung
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.
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.
Über den Autor
Justiniano, Jose; Gopalaswamy, Venky
Inhaltsverzeichnis
PART ONE Practical Design Control Implementation, PART TWO Medical Device Reliability, Conclusion, Acronyms and Definitions, References
Details
Erscheinungsjahr: 2019
Fachbereich: Andere Fachgebiete
Genre: Importe, Medizin
Rubrik: Wissenschaften
Medium: Taschenbuch
Inhalt: Einband - flex.(Paperback)
ISBN-13: 9780367395384
ISBN-10: 036739538X
Sprache: Englisch
Einband: Kartoniert / Broschiert
Autor: Justiniano, Jose
Gopalaswamy, Venky
Hersteller: CRC Press
Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, D-36244 Bad Hersfeld, gpsr@libri.de
Maße: 254 x 178 x 13 mm
Von/Mit: Jose Justiniano (u. a.)
Erscheinungsdatum: 25.09.2019
Gewicht: 0,445 kg
Artikel-ID: 128405444

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