Optimizing SBOMs & Change Control Management for Regulatory Compliance in Medical Device Software
Time: 12:00 pm
day: Day One Track B AM
Details:
- 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 manage these complexities in the context of global submissions