IEC 62304 - Medical Device Software Life Cycle Processes

IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
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Update on IEC 62304 revision - May 2012 - 2013 (TBD)
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Tidge
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Discussions
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Medical Standards for FPGA
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Developer_FPGA
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Different 62304 safety classes for modules in software system
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blackcofee
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FDA Software SDS: how to deal with requirement that it needs to be prospective activity?
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Tidge
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Release Candidate justification and regulatory authorization
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Enternationalist
Enternationalist
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Medical device software - GSPR 6 device lifetime
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d_addams
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Software Safety Classification
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BCQuality76
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"No Risk SOUP"
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drm71
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SOUP soup
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yodon
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Manufacturing flowchart SaMD
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Berto_gi
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SOUP vs Tools vs Test
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Hi_Its_Matt
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"DMR" / Build SOP
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yodon
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Evolution of SW functionalities based on Machine-Learning Algorithms - qualif. of changes (significant/non-significant according to MDCG 2020-3
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Ed Panek
Ed Panek
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Anomalies Documentation
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Bev D
Bev D
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Whether software pre-installed inside the medical device is required to comply with IEC 25051
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kingkingwang
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Do change requests play a role during initial development, before a release took place?
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Wham
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