Webinar – Is your AI software a medical device?

Artificial Intelligence is transforming healthcare, but determining whether your AI solution qualifies as a medical device can be challenging.

Join our free upcoming webinar to gain a clearer understanding of the regulatory landscape for AI-based software. We will explore qualification and classification under medical device regulations, applicable laws and standards, and the pathway to market.

Date: 29 October 2026
Time: 13:00 – 13:45 CET
Cost: Free of charge

Topics covered

• Medical device qualification of AI software
• Software classification under the MDR and other regulations
• Relevant regulations, guidance documents and standards
• Regulatory strategy and market access planning
• CE marking requirements
• Key considerations for quality, risk management and clinical evidence

Meet the speaker
The webinar will be presented by Oscar He Lindholm, Client & Business Development Partner and one of our AI experts at GBA Key2Compliance.

Oscar supports companies in navigating the regulatory requirements for medical devices and AI-based software, helping them find a clear and practical path forward.

A little extra for everyone who joins
Everyone who attends the webinar will receive our practical guide, Is Your Software a Medical Device?, designed to help you take the first steps in determining how your software may be regulated.

All webinar attendees will have the opportunity to book a complimentary 30-minute consultation with Oscar to briefly discuss their software or medical device and any regulatory challenges they may be facing. Booking details will be shared with attendees after the webinar.

Whether you are developing a new AI-based solution or reviewing the regulatory status of existing software, this webinar will help you identify the questions you need to address and plan your next steps.

REGISTER NOW!