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AAMI/IEC 62304 AMD 1:2016

AAMI/IEC 62304 AMD 1:2016

Medical device software - Software life cycle processes, Amendment 1

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Amendment 1 updates the standard to add requirements to deal with LEGACY SOFTWARE, where the software design is prior to the existence of the current version, to assist manufacturers who must show compliance to the standard to meet European Directives. Software safety classification changes include clarification of requirements and updating of the software safety classification to include a risk-based approach

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