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AAMI TIR32 - MEDICAL DEVICE SOFTWARE RISK MANAGEMENT Organization: AAMI
Date: 2004-01-01
Description: Purpose The goal of this TIR is to be a technical reference on risk management for medical devices. It is intended primarily for software engineers, software quality assurance personnel, and those responsible for medical device risk management.
CRC - PHE1368 - SOFTWARE DEVELOPMENT AND QUALITY ASSURANCE FOR THE HEALTHCARE MANUFACTURING INDUSTRIES, THIRD EDITION Organization: CRC
Date: 2002-07-31
Description: Completely revised and updated, this book is a practical guide for anyone involved in all levels of the development and quality assurance of software programs for healthcare products - particularly in the medical device and equipment manufacturing industries.
SAE JA1003 - SOFTWARE RELIABILITY PROGRAM IMPLEMENTATION GUIDE Organization: SAE
Date: 2004-01-01
Description: The Standard describes the requirements of a software reliability program to define, meet, and demonstrate assurance of software product reliability using a Plan-Case framework and implemented within the context of a system application.
CRC - KE10642 - DEVELOPING SAFETY-CRITICAL SOFTWARE : A PRACTICAL GUIDE FOR AVIATION SOFTWARE AND DO-178C COMPLIANCE Organization: CRC
Date: 2013-01-07
Description: The book includes: An overview of how software fits into the systems and safety processes Detailed examination of DO-178C and how to effectively apply the guidance Insight into the DO-178C-related documents on tool qualification (DO-330), model-based development (DO-331), object-oriented technology (DO-332), and formal methods (DO-333) Practical tips for the successful development of safety-critical software and certification Insightful coverage of some of the more challenging topics in safety-critical software development and verification, including real-time operating systems, partitioning, configuration data, software reuse, previously developed software, reverse engineering, and outsourcing and offshoring An invaluable reference for systems and software managers, developers, and quality assurance personnel, this book provides a wealth of information to help you develop, manage, and approve safety-critical software more confidently.
ANS 10.7 - NON-REAL-TIME, HIGH-INTEGRITY SOFTWARE FOR THE NUCLEAR INDUSTRY-DEVELOPER REQUIREMENTS Organization: ANS
Date: 2013-01-01
Description: The requirements in this standard are specified for development of high-integrity software. The intent is to set a minimum level of quality assurance and critical technical process requirements to satisfy due diligence.
CRC - E0312 - MEDICAL DEVICE RELIABILITY AND ASSOCIATED AREAS Organization: CRC
Date: 2000-03-29
Description: It addresses a variety of topics related - directly and indirectly - to reliability, including human error in health care systems and software quality assurance. With emphasis on concepts rather than mathematical rigor, a multitude of examples, exercises, tables, and references, this is one resource that everyone connected to the medical device industry must have.
NASA NPR 7123.1 - NASA SYSTEMS ENGINEERING PROCESSES AND REQUIREMENTS W/CHG 1: 3/7/2014 Organization: NASA
Date: 2013-04-18
Description: Many other discipline areas such as health and safety, medical, reliability, maintainability, quality assurance, IT, security, logistics, and environmental perform functions during project life-cycle phases that influence or are influenced by the engineering functions performed and need to be fully integrated with the engineering functions.

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