Day

June 12, 2009
Company:Terumo Cardiovascular Systems CorpDate of Enforcement Report 6/10/2009 Class:ll PRODUCT Terumo Advanced Perfusion System 1 Central Control Monitor; Catalog number 802100. The Central Control Monitor (CCM) provides a centralized display of system information and on-screen control of all system devices. The CCM combines an embedded computer, a touchscreen, and a graphical user interface. Recall #...
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IEC 62304 and other Emerging Standards Impacting Medical Device Software

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ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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