Open-source software is widely used in SaMD products, but unmanaged dependencies introduce cybersecurity and compliance risks. FDA expects manufacturers to understand and manage these risks effectively.
Open-source software is widely used in SaMD products, but unmanaged dependencies introduce cybersecurity and compliance risks. FDA expects manufacturers to understand and manage these risks effectively.
- FDA expectations for SBOM in SaMD products
- Managing open-source and third-party risks
- SBOM generation and maintenance best practices
- Using SBOMs to support vulnerability response
- SaMD engineering and DevOps teams
- Product security and compliance teams
- Organizations managing complex software stacks