EU-MDR/IVDR regulations may be painful, but they are also painfully clear that post-market surveillance data is "required to be fed into the clinical evaluation process in a timely manner" [Section 6.2.3b] preferably as summary tables of adverse events [Section A7.2d] in your CERs/PSURs.
The gathering and preparation of this data has been notoriously laborious and time-consuming. And for many of our devices, it must be repeated annually.
This session will evaluate a new AI-enabled platform that can create comprehensive adverse event data tables in real-time, across multiple brands or devices, complete with all supporting records.
Learning Objectives:
Explain the capabilities of a new tool for meeting EU-MDR/IVDR submission requirements
Compare and contrast the outputs and structure of AE data tables using different approaches