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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Software Safety Classification
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michael Cejnar
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Requirements management in dev tool (Jira, DevOps, Git etc)
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6
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310
Tidge
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Software change not visible/activated to users
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1
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yodon
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62304: Class C in practice
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6
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367
drm71
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IVDR vs MDR in context of MDSW (overview?)
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0
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181
drm71
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Software validation with IEC 60601-1, 61508-3 or 62304?
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5
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416
Tidge
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MDR MDSW Class IIa / IEC 62304 A ?
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5
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326
Tidge
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Medical Device App sent with tablet
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5
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269
TomQA
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OS and SOUP
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2
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212
drm71
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62304 clause 5.1.1 "Processes"
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2
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184
Tidge
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Expiry date SaMD - WebApp ?
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2
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469
yodon
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Specific Software verification / validation requirements written in a standard?
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5
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626
Tidge
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Requirements for using Open Source Software in Medical Devices - IVD Medical Device
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yodon
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4.1 Quality management system
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10
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tross
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In which process of the IEC 62304 is the SOUP tested?
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3
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397
Tidge
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