IEC 62304 — Software Life Cycle Processes for Medical Device Software Training by Tonex
Medical device software success hinges on disciplined life cycle practices that meet regulatory expectations without stifling innovation. This course translates IEC 62304 into clear, actionable workflows for teams building standalone software and software in a medical device.
You’ll learn how to classify software, define safe architectures, and drive compliant verification and validation while working efficiently with Agile and DevOps. Security is treated as a first-class safety concern, mapping threat controls to risk management and traceability. You’ll connect cybersecurity risk to software safety classes, secure update pipelines, and incident response. The result is predictable compliance, resilient products, and faster releases.
Learning Objectives
- Explain IEC 62304 structure, scope, and key definitions
- Determine software safety classification and its implications
- Build life cycle plans aligned with quality management systems
- Author and maintain compliant requirements, risk, and traceability
- Plan verification and validation that satisfy regulators and engineers
- Integrate Agile, CI/CD, and automation without breaking compliance
- Implement secure development and maintenance practices; include cybersecurity in risk controls and change management
Audience
- Software Engineers and Architects
- Quality and Regulatory Affairs Professionals
- Systems and Safety Engineers
- Product Owners and Project Managers
- DevOps and Release Engineers
- Cybersecurity Professionals
Program Modules
Module 1 – Foundations
- Standard scope and terminology
- Software safety classes A/B/C
- Roles and responsibilities
- Life cycle model and plans
- Interfaces to ISO 14971
- Documentation expectations
Module 2 – Requirements
- User needs to software items
- Safety and risk-derived requirements
- Nonfunctional and security needs
- Traceability strategies end-to-end
- Change control and baselining
- Requirements reviews and quality
Module 3 – Architecture and Design
- Decomposition and software items
- Safety segregation and containment
- Defensive design and fault handling
- Interface control and data integrity
- Design reviews and checklists
- Design outputs and trace links
Module 4 – Implementation and V&V
- Coding standards and static checks
- Unit verification strategies
- Integration sequencing and coverage
- System verification and validation
- Evidence capture in CI pipelines
- Defect handling and closure
Module 5 – Agile and DevOps
- Incremental compliance planning
- DoD/DoR with compliance gates
- CI/CD with regulated controls
- Tool qualification and records
- Automated testing and metrics
- Release readiness and signoffs
Module 6 – Maintenance and Postmarket
- Problem resolution processes
- Field monitoring and feedback
- Patch management and hotfixes
- Cybersecurity updates and SBOMs
- Incident response and CAPA links
- Re-verification and re-validation
Ready to operationalize IEC 62304 and ship compliant, secure medical software with confidence? Enroll with Tonex to equip your team with templates, workflows, and review practices that accelerate approvals and reduce risk.