Day

May 13, 2009
Company:General Electric Medical Systems Information TechnologyDate of Enforcement Report 5/13/2009 Class:ll PRODUCT GE Healthcare CIC Pro” Software Versions 5.0.3, 5.0.6 , 5.0.7, 5.0.8 and 4.1. The CIC Pro” Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult,...
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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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