FDA CDRH 510(k) Creatinine Test System

“Guidance for Industry In Vitro Diagnostic Creatinine Test System”

This guidance was issued July 2, 1998. Like other guidance documents related to IVD tests issued in this time frame, there is a short software section that requires software validation information and a certification statement in the submission. And there is a section on other device validaton information related to the methods and percision and liniarity and the statisics and calculations involved.

SoftwareCPR Keyword: IVD

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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