15:00 - 15:30 Someone (AI) wrote my Clinical Evaluation. Now what?
AI can draft clinical evaluation documentation in seconds, make it look very structured and feel more efficient—but a well-written and looking document is not automatically a defensible clinical evaluation. Florian will look at where expert judgment remains critical and why an independent clinical evaluation review can be the difference between a shiny CER and one that actually stands up to scrutiny.
15:30-16:00 When AI Meets Regulatory Affairs: Who Is Accountable?
In regulatory affairs, “the algorithm decided” is unlikely to satisfy an auditor, regulator, or patient. AI can make decisions in milliseconds, but when something goes wrong, accountability suddenly moves much more slowly. So, who is ultimately accountable? And what does the evolving legal framework actually say?
Presented by: Fabienne Di Gennaro, Co-founder, RegAffinity GmbH
16:00 - 16:30 Will AI solve all my tech-doc problems?
How can AI genuinely reduce the burden of technical documentation and where human expertise remains essential? We will explore the possibilities of using generative AI to structure existing technical documentation and discuss the best possibilities to maintain that documentation through the life-cycle of a device.
Presented by: Anders Emmerich, CEO, Aligned AG
16:30 - 17:00 6 MDR Technical Documentation Pitfalls from a Notified Body's perspective
We present six recurring pitfalls identified during MDR technical documentation assessments, moving from general MDR expectations to their specific implications for Medical Device Software. Using anonymised findings from actual assessments, we share practical recommendations to help prevent similar issues.
Presented by: Alessio Quaranta, Medical Device Product Development Leader, Bureau Veritas Switzerland AG
Time and Place
Date: Tuesday, September 22nd
Time: 15:00 - 17:00 CET
Live Streamed from the Aligned HQ. The Teams link is on the Linked In Event page.
Presentations are held in English.
Target Audience
This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.
About Aligned AG
Aligned AG provides the Aligned eQMS and Aligned Elements Design Control software for medical devices which are built to meet global regulatory requirements without unnecessary complexity.
Our software supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle.
Register today to reserve your seat!
Register on Linked In below. For questions, This email address is being protected from spambots. You need JavaScript enabled to view it..
