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Articles tagged with “aems”

MAUDE to AEMS Data Reconciliation: A Practical Guide

A 2026 guide to reconciling MAUDE, MDR files, openFDA and AEMS: report keys, supplemental updates, device mapping, source timing, and validation controls that preserve analytical lineage.

27 min read

10/13/2026

maude to aems data reconciliation maude aems openfda medical device reporting postmarket surveillance data reconciliation medical device data quality report identifiers

FAERS 2026: Adverse Event Report Data, Top Drugs & Outcomes

A 2026 analyst guide to FAERS adverse event data covering the FDA's new AEMS platform transition, serious outcome rates, top drugs by report volume, signal detection methods, and AI pharmacovigilance case processing.

38 min read

8/1/2026

faers fda adverse event reporting system pharmacovigilance adverse event reporting aems drug safety signals disproportionality analysis pharmacovigilance automation fda faers data 2026 signal detection