Day

November 4, 2014
Sherman Eagles of SoftwareCPR® provides the following summary of some key points from FDA’s webinar on their premarket cybersecurity guidance on October 29. In the webinar FDA noted that the Instructions for Use should include what cybersecurity controls are needed in the use environment, but stated that it is not sufficient for a device to...
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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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