Day Four – 19 June 2025 - CEST Time Zone
- Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL
What are the newest pieces of legislation which have been released relating to software and AI/ML in Europe?
What have the biggest impact on industry?
What's in the pipeline?
Regulatory priorities for the next year
- Malte Knowles Schmidt - Manager Global Service Portfolio SW, AI and Cybersec. for Medical Devices, TÜV SÜD
- Alexander von Janowski - Certification Manager, TÜV AI.Lab
Latest regulatory updates from the US
How different are they from European updates?
Are there places of alignment between the 2 regions?
Where can manufacturers streamline documentation or workload?
The future
US priorities for software and AI/ML in the coming year
- Paula Antunes - Global Regulatory Lead, GRA - RA Digital Health & IVD, Novo Nordisk
Manufacturer obligations for medical AI systems
MDR and AI Act requirements regarding explainability and transparency
Operator obligations for medical AI systems
German and European operator law
Implementation of obligations in inactive processes of manufacturers and operators
- Thorsten Prinz - Senior Medical Devices & Software Manager, VDE Verband der Elektrotechnik Elektronik Informationstechnik e.V.
In this opening half an hour, take the time to reflect on your current software and AI journey and discuss with colleagues
Use the post-it notes provided to write down your top comment, question or concern
These will then be addressed by our expert panel during tomorrow’s final session
Comparison of cybersecurity legislation from both Europe and the US
How do they compare?
Are there places in which one can learn from the other?
How can manufacturers adhere to both sets of regulations, if operating in both regions?
- Tips for best practices
Risk and mitigation techniques for cybersecurity
Dealing with breaches
- Stephen Gilbert - Professor of Medical Device Regulatory Science, Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
- Sravani Sreeram Nagasai - Technical Program Manager, Google
- Introduction to ISO 14971 and its Importance in Software as a Medical Device (SaMD)
- Key Principles and Concepts of the Standard for SaMD
- Overview of the Risk Management Process in SaMD
- Application of ISO 14971 in the Development and Maintenance of SaMD
- Common Pitfalls and Best Practices in SaMD Risk Management
- Paul Evans - Head of Quality Assurance and Regulatory Compliance, Digital Health and Care Wales
- Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
Locking down risk management strategies
Which regulations and guidance reference risk management for AI?
When to start thinking about and implementing risk management
How do you apply risk management principles for AI-enabled devices?
Case study: risk management in action
- Pat Baird - Senior Regulatory Specialist, Philips
- Arun Mathew - Associate Director, Quality Systems (Risk Management), AbbVie
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
What are regulatory sandboxes and what are they used for?
What information do we have on how these will be established in member states?
What do manufacturers need to be aware of?
Can you develop AI without the use of sandboxes?
What opportunities do sandboxes provide and how can they help shape the future of device and diagnostic development?
- Stephen Gilbert - Professor of Medical Device Regulatory Science, Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
- Alexander von Janowski - Certification Manager, TÜV AI.Lab