FDA Intel Pentium Problem Letter

FDA CDRH’s letter 14-Feb-1994 regarding the Intel Pentium floating point calculation defect. This is a good example of how serously FDA takes problems with components and indicates what FDA expects of the manufacturer.

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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