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MEDICAL DEVICE SOFTWARE RISK MANAGEMENT
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Available format(s): Hardcopy, PDF
Withdrawn date: 31-10-2017
Language(s): English
Published date: 31-12-2015
Publisher: Association for the Advancement of Medical Instrumentation
Glossary of equivalent standards Committee representation Foreword Introduction 1 Scope2 References3 Definitions4 Perspective 1: Basic concepts of medical device software risk management5 Perspective 2: Software considerations in medical device risk management6 Perspective 3: Software risk management within a software life cycle7 Perspective 4: Soft factors in software risk managementAnnexesA - Direct causes sample tableB - Indirect causes and risk control measures table (failures due to unpredictable behaviors)
Describes a framework within which experience, insight, and judgment are applied systematically to reduce medical device risks.
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