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Guidance for Ensuring Your Clinical Study

Follow This Guide To Ensure Success

An increasing trend in the clinical device research industry is the inclusion of the International Organization for Standardization 14155:2011 (ISO 14155) guidelines into research protocols. The goal of this paper was to introduce some suggestions on how to set up a study for successful compliance with both the FDA regulations and ISO 14155, giving some practical advice on how these additional ISO 14155 requirements can be added.

Compliance with ISO14155

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