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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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ISO 13485:2016 - Medical Device Quality Management Systems
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
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ISO 13485 and Class 1 Medical Device - FDA thinking
markl368
Apr 23, 2014
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Feb 13, 2024
Eloisa0819
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Trusting ISO 13485 Certification of a Supplier... A Sad Story
MIREGMGR
Sep 8, 2011
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Jul 6, 2017
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Apr 16, 2021
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ISO 13485 - Medical Device Quality Management System Standard
Marc
Apr 12, 2010
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Jun 9, 2020
DuncanGibbons
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ISO 13485:2015 Pre-Release News and Discussion
Marcelo
Apr 14, 2011
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Jun 18, 2015
Marcelo
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The US's FDA and other Medical Device Related Forums
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Oct 18, 2009
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Oct 18, 2009
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Discussions
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Out of Spec CNC
TroyM
Friday at 9:49 AM
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Friday at 3:02 PM
Ron Rompen
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Validation of Software regarding ISO 13485:2016
Denzel
Mar 7, 2024
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Mar 10, 2024
Denzel
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Revision Reset for documents and components
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Feb 28, 2024
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Supplier components
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Mar 8, 2024
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Mar 9, 2024
Enternationalist
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ISO 13485 - Control of Records (4.2.5) question
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Feb 5, 2024
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Advisory Notice
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