Building Confidence in AI: Validating Reliability, Demonstrating Business Value & Enabling Responsible Adoption in Regulated Environments
1:31 pm - Tuesday 8th December 2026
As AI moves from experimentation to deployment, MedTech organisations face growing pressure to ensure AI-generated outputs are reliable, explainable and fit for purpose. While AI promises significant improvements in efficiency and decision-making, many software, quality and regulatory leaders are still grappling with how to validate AI systems, define appropriate oversight, measure success and justify continued investment. This interactive workshop will bring together industry leaders to explore practical frameworks for building trust in AI, balancing innovation with accountability, and creating the evidence needed to support adoption at scale.
Industry experts will cover:
- Anticipating evolving AI regulatory expectations to make better development decisions today by identifying common principles emerging across the AI Act, MDR and global regulatory frameworks
- Translating broad AI concepts into practical requirements for medical devices through interpreting expectations around transparency, human oversight and ML systems for real-world MedTech products rather than generic chatbot-focused guidance
- Developing pragmatic strategies for global compliance and risk management by documenting regulatory rationale, sharing best practices, engaging with authorities and aligning compliance activities with both company values and future worldwide market access objectives
