Day

December 5, 1996
WARN 12/05/96 Lady of the Lake Blood Bank Deviations noted included: 1) lack of proper validation of computer system software; 2) failure to establish and implement adequate computer security in allowing software vendor unrestricted modem access and not consistently documenting this access; 3) not conducting a secondary review of computer software modifications; 4) lack of...
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SoftwareCPR Training Courses:

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

Or just email training@softwarecpr.com for more info.

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