Tura Ouellette
Company: Straumann
Job title: Director Regulatory Affairs NAM
Seminars:
Optimizing SBOMs & Change Control Management for Regulatory Compliance in Medical Device Software 12:00 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 Track B AM