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.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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