Day

September 24, 2001
WITHDRAWN BY FDA Feb 2003 as not representative of their current thinking. FDA has released it as a draft validation Guidance on Part 11 Electronic Records; Electronic Signatures. These guidance documents were developed by FDA’s Part 11 Compliance Committee. This is a draft, and industry comments will be important in shaping the final guidances. Submit...
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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.

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