Tura Oulette
Company: Straumann Group
Job title: Director Regulatory Affairs
Seminars:
Optimizing SBOMs & Change Control Management for Regulatory Compliance in Medical Device Software 4:15 pm
Best practices for integrating SBOMs into the software development lifecycle to meet FDA, EU MDR, and other regulatory requirements, ensuring end-to-end traceability Establishing robust procedures to handle software changes post-market, ensuring compliance with change control regulations while maintaining device safety and performance Understanding regional differences in SBOM requirements and change management practices, and how to…Read more
day: Day One Lunch & Networking
Fireside Chat: Adapting to FDA & CDRH Changes: What’s Ahead for Software-Driven Devices 12:30 pm
How internal restructuring and funding pressures at the FDA/CDRH may affect review timelines, submission predictability, and early engagement (e.g. pre-subs) Preparing for increased reviewer turnover – and what it means for continuity, communication, and expectations across the submission lifecycle Best practices for clearly documenting architecture, validation, and risk for AI/ML and connected devices – to minimize…Read more
day: Conference Day One Morning