January 9, 2016

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January 9, 2016

Jan

$SCPR 62304 comparison with FDA by safety class$

January 9, 2016Alan KusinitzBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. It contains a training aid that provides an overview comparison between the 2015 Amendment of IEC 62304 and FDA requirements based on 62304 Safety Classes. SCPRed_SoftwareCPR-FDA-62304SafetyClasscomparisonTrainingAide

Jan

FDA issues 2016 planned guidance list

January 9, 2016Alan KusinitzNews

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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$SCPR 62304 comparison with FDA by safety class$

FDA issues 2016 planned guidance list

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