See how an Adverse Event (AE), Serious Adverse Event (SAE), Adverse Device Effect (ADE), Serious Adverse Device Effect (SADE), and Unanticipated Serious Adverse Device Effect (USADE) differ, plus device deficiencies, so the whole team speaks the same language.
Know when safety events and device deficiencies have to go to the sponsor, the IRB, and others, so a deadline never slips by.
Use it as a checklist when you're reviewing an event, documenting the details, and deciding what to escalate, whether you're a coordinator, investigator, or sponsor.
Device safety terms and timelines, in one place.
This printable pulls together the safety terms and reporting expectations that matter most in medical device trials. It covers events from an AE to a USADE, includes device deficiencies, and lays out reporting timelines consistent with ISO 14155:2020 and 21 CFR 812. Instead of flipping between guidance documents, your team gets the essentials in one place. Whether you're a new coordinator, a student, an investigator, or a sponsor, it makes it easier to recognize an event, decide what has to be reported, and know who needs to hear about it. Keep it in your regulatory binder, training packet, or device-trial toolkit, you'll use it more often than you expect. Licensed for individual or single-site use. Full licensing details can be found at catalog.cliniq.academy/pages/license-agreement.
Walk into device safety reporting knowing the terms cold.
Your quick reference for AE, SAE, ADE, SADE, USADE, and device deficiencies, built for sites, investigators, students, and sponsors who want clear, confident reporting.
$5.00