Watch the webinar recording
In recent years, the incorporation of AI and Machine Learning (AI/ML) into medical devices has increased rapidly across startups and large MedTech companies. At the same time, Europe’s regulatory requirements have also undergone significant changes.
Join TÜV SÜD’s Global Portfolio Manager, Malte Knowles Schmidt, for an expert-led on-demand webinar to learn about the general requirements for AI/ML-enabled medical devices, key timelines, and how to achieve compliance for entry into the European market.
This on-demand webinar will also cover the current regulatory environment for AI/ML-enabled medical devices under the EU Medical Device Regulation (MDR) and provide an outlook on how the EU AI Act will change the status quo.
Key takeaways:
- AI Product assessment under EU MDR
- General requirements for devices incorporating Artificial Intelligence and Machine Learning (AI/ML).
- EU AI Act Timeline and relevant Players
- Conformity Assessment under the EU AI Act
Practical steps to achieve compliance and market entry.
Who should watch the on demand webinar:
- Small and medium-sized MedTech companies, startups, and innovators developing AI/ML-enabled medical devices.
- Regulatory professionals seeking clarity on EU MDR & AI Act requirements.
- Product developers and compliance teams preparing for European market entry.
Malte Knowles Schmidt
Global Portfolio Manager SaMD, AI and Cybersecurity, TÜV SÜD
