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MEDICAL DEVICE SOFTWARE VERIFICATION, V: Verification, Validation, and Compliance - Hardcover

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9781596934221: MEDICAL DEVICE SOFTWARE VERIFICATION, V: Verification, Validation, and Compliance
Hardcover
ISBN 10: 1596934220 ISBN 13: 9781596934221
Verlag: Artech House, 2010

Inhaltsangabe

Here's the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software. Offering a much broader, higher-level picture than other books in this field, this book helps professionals think critically about software validation -- to build confidence in their software's safety and effectiveness. The book presents validation activities for each phase of the product lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process. From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, and in compliance with regulations.

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Verlag
Artech House
Erscheinungsdatum
2010
Sprache
Englisch
ISBN 10 
1596934220
ISBN 13 
9781596934221
Einband
Gebundene Ausgabe
Auflage
1
Anzahl der Seiten
446
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
GPSR Kontakt
gpsr@libri.de

Europaallee 1
Bad Hersfeld
36244
Deutschland