Secure Product Development Framework (SPDF) Fundamentals Training by Tonex
Elevate your medical device development with a practical, regulator-ready Secure Product Development Framework. This course shows how to embed security thinking into requirements, architecture, coding, verification, and postmarket change control—without slowing delivery. You’ll learn how to turn FDA expectations into clear, auditable engineering practices and evidence. Impact on cybersecurity is front and center: participants will translate threat models into design controls, trace mitigations across the lifecycle, and generate defensible documentation for submissions. By the end, teams can demonstrate that cybersecurity was integrated end-to-end and sustain it as products evolve in the field.
Learning Objectives
- Explain SPDF concepts and map them to the total product lifecycle
- Build secure-by-design architectures aligned to risk and intended use
- Operationalize secure SDLC practices for embedded and connected devices
- Produce FDA-ready security documentation and objective evidence
- Align engineering, quality, and regulatory workflows for speed and rigor
- Show measurable impact on cybersecurity through traceable controls and metrics
Audience
- Product Managers
- Systems and Software Engineers
- Quality and Regulatory Affairs Specialists
- Security Engineers and Architects
- Compliance and Risk Managers
- Cybersecurity Professionals
Module 1 – SPDF Foundations
- SPDF scope and principles
- Lifecycle integration points
- Roles and RACI alignment
- Security policies and SOPs
- Evidence and traceability
- Metrics and KPIs
Module 2 – Secure by Design
- Threat modeling methods
- Security requirements derivation
- Trust boundaries and assets
- Architecture patterns selection
- Cryptography and key handling
- Resilience and safety co-engineering
Module 3 – FDA Design Docs
- 510(k)/PMA security expectations
- Cybersecurity management plan
- SBOM and third-party governance
- Risk analysis and mitigation tables
- Testing summaries and results
- Postmarket update strategy
Module 4 – SDLC Modernization
- Embedded DevSecOps pipelines
- Secure coding standards
- Static and composition analysis
- Secure build and signing
- Automated unit/integration tests
- Deployment and update controls
Module 5 – Verification and Risk
- Security verification strategy
- Penetration and fuzz testing
- Abuse-case validation
- Vulnerability handling process
- Risk acceptance rationale
- Evidence packaging and reviews
Module 6 – Governance and Evidence
- Configuration and change control
- Supplier and SBOM assurance
- Field monitoring and PSUR inputs
- Incident response and recall ties
- Audit readiness and mock reviews
- Continuous improvement loop
Equip your team to deliver safer, compliant devices with security built in from concept to postmarket. Enroll in SPDF Fundamentals by Tonex to turn FDA requirements into repeatable engineering practice and produce submission-ready cybersecurity evidence with confidence.