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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IEC 62304, Multiple software systems in one medical device
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6
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659
DanMann
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IEC 62304 vs US FDA Software documentation requirement
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4
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652
Tidge
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Service Tool application for Medical Device
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3
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442
Tidge
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5.5.1 Implement each SOFTWARE UNIT
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10
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734
tross
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Demonstrate separation of SW elements (how)
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1
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327
Tidge
T
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Software Safety Classification 62304 Control system/Protective system
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3
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515
OccamMan
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T
IEC 62304 - Integration Plan, what is it?
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3
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611
Tidge
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New guidance "Content of Premarket Submissions for Device Software Functions"
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7
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789
DanMann
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M
Looking for help to get audit for IEC 62304 in Asia Pacific
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1
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365
shimonv
shimonv
M
Initial Importer/Distributor and Software Validation
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6
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1K
Enternationalist
Enternationalist
E
SOUP as a "Software Unit"?
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4
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501
Tidge
T
T
Risks related to Software of Unknown Provenance (SOUP)
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6
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443
shimonv
shimonv
M
Software Safety classification for two independent systems in one device
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3
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511
FelipeSchneider
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T
SaMD expiry date
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4
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443
DanMann
D
T
SaMD labeling requirements - MDR
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5
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988
MaHoDie
MaHoDie
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