SBOM in 90 Minutes (FDA Focus) Fundamentals Training by Tonex
Fast-paced yet practical, this course distills the essentials of Software Bill of Materials (SBOM) for FDA-regulated products. Participants learn why SBOMs matter, where they fit in device life cycles, and how to operationalize them across engineering, quality, and regulatory workflows. Strong emphasis is placed on aligning SBOM outputs with premarket and postmarket expectations without slowing delivery. Cybersecurity resilience improves when components, versions, and vulnerabilities are visible, traceable, and governed. SBOM practices reduce attack surfaces, speed response to emerging CVEs, and strengthen coordinated disclosure. The result is clearer supplier accountability, faster audits, and safer, more compliant medical technology.
Learning Objectives
- Explain SBOM concepts, data fields, and FDA relevance
- Map SBOM to product lifecycle, QMS, and change control
- Select formats and tools that enable automation and scale
- Integrate SBOM into procurement and supplier assurance
- Apply risk triage and remediation workflows to SBOM findings
- Improve incident readiness and patient safety with actionable SBOMs
- Strengthen cybersecurity posture by using SBOMs to detect, prioritize, and track vulnerabilities
Audience
- Product Managers and Owners
- Systems and Software Engineers
- Quality and Regulatory Affairs Specialists
- Supply Chain and Vendor Managers
- Security and Compliance Leads
- Cybersecurity Professionals
Course Modules
Module 1 – SBOM Essentials
- SBOM purpose and value
- Minimum data elements
- FDA expectations overview
- Healthcare threat landscape
- Component and version accuracy
- Transparency versus exposure
Module 2 – Formats and Standards
- SPDX fundamentals
- CycloneDX essentials
- SWID and legacy artifacts
- Crosswalks and conversions
- Tool interoperability basics
- Choosing the right format
Module 3 – Building SBOMs
- Source and binary generation
- Build pipeline integration
- Third-party and OSS mapping
- Handling proprietary modules
- Capturing transitive deps
- Versioning and provenance
Module 4 – Validating Quality
- Completeness and accuracy checks
- Duplicate and alias resolution
- License identification sanity
- Metadata normalization rules
- Signing and attestation basics
- Storage, retention, retrieval
Module 5 – FDA and Compliance
- Premarket submission alignment
- Postmarket monitoring linkage
- Coordinated disclosure ties
- QMS and change control hooks
- Procurement and contracts fit
- Evidence for audits and reviews
Module 6 – Risk to Action
- Vulnerability correlation flow
- CVE/CVSS triage methods
- Exploitability and impact tags
- Remediation and exceptions
- Communication to stakeholders
- Metrics, KPIs, and reporting
Ready to turn SBOM from a checkbox into a capability that accelerates compliance and hardens security? Enroll now to master the essentials in 90 minutes and leave with practical steps, templates, and a roadmap you can apply immediately across engineering, quality, and regulatory teams.