Mercure Hotel MOA Berlin, Berlin, Germany,
Hybrid Event I Attend In-Person or Digitally
19 - 20 June 2025
Software and AI for Medical Devices and IVDs
Stay Ahead of the Evolving SaMD and AI regulations. Demonstrate Software Safety and Efficacy. Ensure Data and Cybersecurity Best Practice.
Plus, Dive into the Details of the EU AI Act in a Dedicated 1-Day Workshop!
Align with the Latest Software and AI Regulatory Updates to Ensure Certification
Apply the current regulations, standards and frameworks for compliance
Navigate the European landscape for Medical Device Software (MDSW) and Artificial Intelligence (AI) with TÜV SÜD
Deep dive into the US regulatory ecosystem with insights from Novo Nordisk
Support software submissions with sufficient clinical data with learnings from Axon Lawyers
Compare and contrast certification experiences with industry case studies
Take advantage of the capabilities of generative-AI with examples from Ascensia Diabetes Care
Explore large language model application and apply best practices with insights from Technische Universität Dresden
Unlock learnings from InsideAI's successful SaMD certifications
Drive industry innovation with multi-stakeholder panels
Understand the latest cybersecurity requirements to ensure device and data safety
Get ahead of risk management planning by understanding ISO 14971
Identify and utilise regulatory sandboxes to further develop AI capabilities
EU AI Act Deep Dive Workshop
Wednesday 18 June
- Comprehend the intricacies of the EU AI Act
- Understand the implications for manufacturers
- Identify the EU AI Act’s place in the regulatory web
- Collect and demonstrate desirable clinical data
- Ensure lifelong compliance with effective PMS planning
- Enhance AI efficacy by exploring potential risks
