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.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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