Review
Medical device incident investigation
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- PMID: 17487098
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Review
Medical device incident investigation
Biomed Sci Instrum.
2007.
Abstract
FDA Medical Device Reporting regulations require investigation and reporting of certain device-related incidents. Medical device incident investigation is also a key component of risk management for healthcare delivery organizations. However, the fundamental objective of incident investigation is to identify the root cause of an incident and mitigate the risk (probability x severity) of recurrence.
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