Medical Device Incident Reporting AND Investigation Scheme Iris
TGA (CWLTH) resource. Rules Mate indexes this as part of the Australian compliance corpus. Click through for the regulator's primary source.
https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-we-manage-your-medical-device-adverse-event-report/medical-device-incident-reporting-and-investigation-scheme-iris
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