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[DOCX File]Introduction - Software in Medical Devices, by MD101 ...
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Add the standard references to the table above. It may include ISO 14971, ISO 13485, IEC/TR 80002-1, IEC 62304, amongst others. Risk management during software development. This chapter covers the risk management process and organization during the software …
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Software Architectural and Detailed Design. Basic Profile. Notes: This document is the intellectual propriety of its author’s organization. However, information contained in this document is free of use. The distribution of all or parts of this document is authorized for non commercial use as long as the following legal notice is mentioned:
[DOC File]Software Architectural and Detailed Design
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ISO/IEC 24765, Systems and Software Engineering Vocabulary. Syn. design constraints, non-functional requirement. See also: functional requirement. NOTEfor example, software performance requirements, software external interface requirements, software design constraints, and software quality attributes.
[DOCX File]Deployment Package – Software Requirements Analysis
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Templates Repository for Software Development Process (click here) ... The creation and the maintenance of Validation Protocols, ... (§7.5.2 of ISO 13485) 1.2. Is the computerized system used in the quality management system? (§4.1.6 of ISO 13485:2016) 1.3.
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