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21CFR820
A fundamental requirement for any controlled process is to have the documentation associated with the process to be “controlled.”  What do we mean by controlled?  Document control implies that one can distinguish one revision of a document from another revision.  It also implies that a particular revision is retrievable and unblemished – that is, five...
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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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