Guidance on the Latest IMDRF Codes For The Argus Application (Doc ID 2899039.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.2.3 and later
Information in this document applies to any platform.

IMDRF has also recently published the Adverse Event Reporting Terms for Medical Device Reports.
Below are the links to the latest Annexes.

IMDRF Link Published on 08-Mar-2022:
https://www.imdrf.org/documents/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes

FDA Link Published on 22-Aug-2022:
https://www.fda.gov/medical-devices/mdr-adverse-event-codes/coding-resources-medical-device-reports

Does Oracle have any guidance document on how to upload/update the latest terms as published in various Annexes into the Argus application?

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