
June 17, 2025

Interlynk
Understanding SBOM, SOUP, COTS, and OTS in Medical Device Cybersecurity
Medical device makers must manage SBOM, SOUP, COTS, and OTS to meet FDA and IEC 62304 requirements. SBOMs ensure software transparency, while SOUP and COTS need risk assessment and validation. Understanding these components is key to securing devices, reducing vulnerabilities, and staying compliant with global cybersecurity regulations.