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FDA CONFORM HF VALIDATION REPORT

An HF validation report consists of all information that is relevant for a final evaluation if a medical device can be used safely and effectively. This includes all setup relevant aspects and rationales i.e. for selecting the intended user group, use environment, etc. The main component is a detailed analysis of all observed use errors, close calls, and operational difficulties, based on a thorough root cause analysis.


We provide the report in FDA’s recommended format that promises a faster turnaround in reviewing the report as the FDA teams do not need to get used to your format but find the data in a familiar structure.

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