FDA CDRH Draft Ventilator 510(k) Guidance

FDA CDRH “Reviewer Guidance for Ventilators” Draft July 1995. Section 7 addresses software documentation requirements for ventilator submissions.

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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