FDA Secure Product Development Framework Workshop by Tonex
Accelerate product quality and trust with a practical, end-to-end approach to the FDA’s Secure Product Development Framework (SPDF). This workshop connects regulatory expectations with real engineering workflows—from concept and risk assessment to verification, release, and post-market oversight. Participants learn how to embed security controls, evidence generation, and documentation into everyday development without slowing delivery.
Cybersecurity is treated as a product safety imperative, not an afterthought, aligning threat modeling, SBOMs, and coordinated vulnerability disclosure with FDA expectations. You will leave with actionable checklists, role-specific responsibilities, and governance patterns that make compliance repeatable and defensible in audits.
Learning Objectives
- Translate FDA SPDF expectations into engineering tasks
- Build a risk-based security plan that scales across product lines
- Map development artifacts to premarket submission requirements
- Operationalize SBOM creation, review, and update governance
- Establish coordinated vulnerability disclosure and patch workflows
- Strengthen product safety and resilience with cybersecurity woven into design, testing, and maintenance
Audience
- Product Managers
- Systems and Software Engineers
- Quality and Regulatory Affairs Professionals
- Security Engineers and Architects
- Compliance and Risk Managers
- Cybersecurity Professionals
Module 1 – SPDF Foundations
- SPDF purpose and scope
- Key FDA terminology
- Roles and responsibilities
- Lifecycle alignment concepts
- Evidence and traceability basics
- Common compliance pitfalls
Module 2 – Risk Management
- Hazard vs threat mapping
- TARA and STRIDE selection
- Security requirements derivation
- Risk acceptance criteria
- Control selection rationale
- Residual risk documentation
Module 3 – Secure Design
- Secure architecture patterns
- Data flows and trust zones
- Secure coding standards
- Cryptography use decisions
- Identity and access models
- Safety–security co-engineering
Module 4 – Verification Readiness
- Security test strategies
- Static and dynamic analysis
- Fuzzing and robustness testing
- SBOM generation practices
- Penetration test scoping
- Evidence packaging methods
Module 5 – Release and Handoff
- Secure build and signing
- Configuration baselines
- Documentation for submissions
- Vulnerability disclosure setup
- Patch and update policies
- Supplier assurance gates
Module 6 – Postmarket Security
- Monitoring and triage flows
- Vulnerability intake handling
- Risk re-evaluation triggers
- Remediation prioritization
- Field update verification
- Metrics and continuous improvement
Ready to embed security and compliance into your development lifecycle with confidence? Enroll now to equip your team with repeatable practices, compliant documentation, and a clear roadmap to FDA-aligned secure product delivery.