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.
FAQs
M
  • Sticky
Update on IEC 62304 revision - May 2012 - 2013 (TBD)
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61
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39,044
Tidge
Discussions
glork98
IEC 62304:2006/AMD1:2015 Checklist .xls file attached
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37,593
yodon
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What JIRA Software workflows you use for your software lifecycle?
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15
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Tidge
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Can SaMD consist almost entirely of Software of Unknown Provenance (SOUP)?
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143
CharmaineK
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Software Safety Classification and Legacy Software
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231
Tidge
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SaMD labeling requirements - MDR
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200
TomQA
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EN 62304:2006/AC:2008 vs IEC 62304:2006/Amd 1:2015
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139
Ronen E
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Determination of Software/system end-of-life
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838
colinkmorgan
MaHoDie
Where to show the Software version
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350
MaHoDie
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What are "typical software risks"? Is IEC/TR 80002-1 a good place to look for a list
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4,386
sagai
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IVD Device Software - Risk Classification
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16
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1,247
ThatSinc
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Registration of MD software
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272
iam1235
Sravan Manchikanti
Software Risk Management & probability of occurrence as per IEC 62304
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9
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2,842
vspokkuluri
K
SOUP (Software of Unknown Provenance) Anomaly Documentation
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7
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2,139
mvroops
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Artificial Intelligence/Machine Learning and 62304
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860
erkan
S
Functionality of software in countries with different legal requirements
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2
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294
SequencingJames
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