Applying Corrective and Preventive Action to Clinical Engineering

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Abstract

Corrective and Preventive Action (CAPA) is well recognized in the medical device industry as a Food and Drug Administration (FDA) requirement and perhaps as a good thing even if the FDA did not require it. Although there is no comparable requirement in clinical engineering, the idea of CAPA may have merit as a formal structure for being responsive to medical device issues that arise during their life cycle. A recasting of the FDA’s CAPA regulation into a form suitable for clinical engineering is presented here, along with a rationale and potential pitfalls.

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