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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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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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Sticky
Update on IEC 62304 revision - May 2012 - 2013 (TBD)
Marcelo
May 4, 2012
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61
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41K
Oct 4, 2021
Tidge
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Discussions
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"DMR" / Build SOP
drm71
Monday at 5:44 AM
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60
Monday at 9:45 AM
yodon
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Manufacturing flowchart SaMD
TomQA
May 10, 2023
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7
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702
Friday at 7:12 AM
DanMann
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Evolution of SW functionalities based on Machine-Learning Algorithms - qualif. of changes (significant/non-significant according to MDCG 2020-3
Galac
Apr 5, 2024
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6
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203
Apr 22, 2024
Ed Panek
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Release Candidate justification and regulatory authorization
Galac
Apr 16, 2024
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2
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120
Apr 19, 2024
mihzago
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Anomalies Documentation
QuinnM
Apr 16, 2024
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6
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160
Apr 16, 2024
Bev D
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Whether software pre-installed inside the medical device is required to comply with IEC 25051
kingkingwang
Mar 27, 2024
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2
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226
Mar 27, 2024
kingkingwang
K
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Do change requests play a role during initial development, before a release took place?
ein_stein_sein
Mar 2, 2024
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4
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297
Mar 25, 2024
Wham
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Parallel Developments with different regulatory requirements (RUO etc)
drm71
Mar 8, 2024
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5
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239
Mar 20, 2024
drm71
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Help with Agile in MedTech
drm71
Mar 19, 2024
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264
Mar 20, 2024
drm71
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Design Specification for the second edition of IEC 62304
dgrainger
Mar 19, 2024
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0
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176
Mar 19, 2024
dgrainger
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Requirements 5.2.2 b SW System I/O vs g Data Defs/DBs
drm71
Mar 11, 2024
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209
Mar 14, 2024
Tidge
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Software Architecture
tross
Mar 7, 2024
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191
Mar 12, 2024
tross
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Review/Recommendations: requirements management tools/software
drm71
Mar 12, 2024
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166
Mar 12, 2024
yodon
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Software Safety Classification
ratamatafon
Sep 28, 2023
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1K
Mar 8, 2024
michael Cejnar
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Requirements management in dev tool (Jira, DevOps, Git etc)
drm71
Mar 6, 2024
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6
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247
Mar 7, 2024
Tidge
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Medical Device Related Standards
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