Software Lifecycle (IEC 62304) + Security Lifecycle Integration Essentials Training by Tonex
Built for modern medical software teams, this course connects IEC 62304 lifecycle rigor with IEC 81001-5-1 secure development practices to create one coherent, audit-ready operating model. Participants learn how to align safety risk control with threat modeling, harden design and code, and produce evidence that satisfies notified bodies and regulators. The result is faster approvals and fewer post-market surprises. Impact on cybersecurity is front and center: you will embed security controls into lifecycle gates, verify and validate them with traceable tests, and sustain them through maintenance and vulnerability handling. Ultimately, you will reduce attack surface, prevent exploit-driven safety hazards, and elevate stakeholder trust.
Learning Objectives:
- Map IEC 62304 processes to IEC 81001-5-1 secure development requirements
- Build integrated plans for risk, configuration, and change control
- Apply threat modeling and misuse scenarios to safety-critical functions
- Design defensible architectures and code with security patterns
- Generate auditable verification and validation evidence for security
- Strengthen cybersecurity posture by embedding controls into lifecycle checkpoints
Audience:
- Software Engineers and Architects
- Quality and Regulatory Professionals
- Product and Engineering Managers
- Verification and Validation Specialists
- Risk and Compliance Leads
- Cybersecurity Professionals
Course Modules:
Module 1 – Standards Alignment
- 62304 process overview
- 81001-5-1 essentials
- Integrated lifecycle map
- Roles and RACI clarity
- Tailoring by class/risk
- Procedures and templates
Module 2 – Secure Planning
- Software development plan
- Security plan integration
- Risk and threat scope
- Tool qualification basics
- Supplier and SBOM policy
- Change control strategy
Module 3 – Secure Requirements
- Safety to security linkage
- Misuse and abuse cases
- STRIDE and PASTA options
- Security requirements writing
- Traceability to controls
- Acceptance criteria definition
Module 4 – Design and Coding
- Secure architecture patterns
- Least privilege and trust
- Data protection by design
- Input validation strategy
- Secure coding checklists
- Code review workflows
Module 5 – V&V for Security
- Test strategy and matrix
- Security unit tests
- Interface and API tests
- Penetration test scoping
- Risk-based coverage mapping
- Objective evidence capture
Module 6 – Evidence and Review
- Traceability end-to-end
- Test evidence for NB
- Cybersecurity dossier build
- Postmarket surveillance flow
- Vulnerability handling process
- Metrics and continual improvement
Ready to unify safety and security under one compliant lifecycle and accelerate your next audit review? Enroll your team in Tonex’s Software Lifecycle (IEC 62304) + Security Lifecycle Integration Essentials and build a defensible, scalable, and audit-ready development system that stands up to regulators and real-world threats.