Now in its tenth year, the conference brings together regulatory affairs professionals from across the medical device and in-vitro diagnostics sector to discuss market authorization under MDR, FDA, and related regulatory developments.  

Aravinda Kumaran’s session, "Bringing AI-Powered Medical Devices to Market: Lessons from EU Technical Documentation and the Road to FDA Submission," will share SCARLETRED's experience navigating regulatory approval for AI-powered medical devices in Europe and the US.

The talk will cover three areas:

1. An introduction to SCARLETRED: Aravinda Kumaran will talk about the history of SCARLETRED and the development of Scarletred®Vision, our CE-certified Software as a Medical Device (SaMD) powered by ARORA®AI.
2. EU regulatory submission: The talk will give an exclusive look behind the scenes at how SCARLETRED prepared and filed its technical documentation under the EU Medical Device Regulation (MDR), including the submission strategy and the practical steps involved in the transition.
3. Roadmap to FDA: Key milestones to consider when planning a submission strategy for the US market. Attendees may listen to practical insights into what it takes to bring an AI-powered medical device to market in both the EU and the US.

Registration for the LISAvienna Regulatory Affairs Conference is open until October 8, 2026, at www.b2match.com/e/lisavienna-reg26.

Save the date:

• October 15, 2026, 13:20-14:35

• LISAvienna Regulatory Affairs Conference (#REG26)

• Apothekertrakt, Schloss Schönbrunn, Vienna, Austria.