IMDRF codes usage in Failure Mode Effect Analysis (FMEAs) | HCLTech

International Medical Device Regulators Forum (IMDRF) is used for Adverse Event (AE) reporting related to medical devices and in vitro diagnostics, adverse event terminology and coding system. This is anticipated to improve signal detection by adverse event management systems empowering a faster response by both industry and regulatory authorities, for manufacturers (including local distributors/authorized representatives). It provides consistency for manufacturers and managing multiple coding systems when preparing medical device adverse event reports for multiple jurisdictions to avoid burden.

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