Clinical evaluation and post-market surveillance both depend on continuous monitoring of published safety data for adverse events, recalls, and field safety corrective actions. Whether assessing equivalent devices before market access or tracking safety signals after - the challenge is the same: While avaAESearch[1] already automates the search and import of safety-relevant data from national authorities such as the FDA's MAUDE and Recall directly into Polarion, many other sources still require manual searching, filtering, and data transfer - pulling expert resources away from what actually matters: evaluating findings and deriving appropriate actions.

A new connector developed in cooperation with Flinn changes that. Flinn's AI-powered research engine takes over the search across additional sources that previously required manual effort and feeds structured results directly into avaAESearch. No more switching between database interfaces, comparing report numbers, or re-entering data by hand.

The result: comprehensive safety monitoring from data collection to documented assessment - fully integrated in Polarion, fully traceable, and designed to give your experts more time for the work that requires their judgment and expertise.

An industry stakeholder is going to join in during the demo to evaluate the customization options and challenge the workflow for the industry's individual needs.

What we will cover

• avaAESearch 
  How avaAESearch digitalizes adverse event, recall, and FSCA monitoring in Polarion today: automated database interfaces, structured evaluation workflows, and seamless traceability related procedures, such as clinical evaluation or risk management.
• The New Flinn Connector 
  How Flinn's AI-powered research engine connects to avaAESearch, which additional data sources it covers, and how results are delivered directly into your Polarion environment - structured and ready for evaluation.
• Live Demo
  The integrated end-to-end process in action: from AI-powered search across multiple databases through structured import to documented evaluation - all within a single platform.
• Outlook
  What comes next on our integration roadmap.

Who should attend

• Clinical Affairs, Risk Management and Regulatory Affairs professionals involved in clinical evaluation, post-market surveillance, and risk management activities
• Quality managers seeking efficient, auditable processes for safety data management
• PLM/ALM tool owners evaluating post-market surveillance solutions for Polarion environments
• Anyone whose team is still searching safety databases manually

[1] Formerly known as avaAdverse