IEC 62304 — Software Life Cycle Processes for Medical Devices Fundamentals Training by Tonex
Modern medical software must be safe, traceable, and ready for audits—yet also agile enough to evolve with clinical needs. This course demystifies IEC 62304, translating the standard into practical activities, artifacts, and role responsibilities across the software life cycle. You will learn how to engineer risk-controlled features, build defensible documentation, and collaborate effectively with quality and regulatory teams. Secure design is integrated throughout: threat-aware requirements, secure coding, and resilient maintenance practices. Strong cybersecurity controls protect patient data and device integrity. You will leave with a structured roadmap to implement, assess, and continuously improve compliant development workflows.
Learning Objectives
- Interpret IEC 62304 clauses and map them to day-to-day engineering practices
- Build a life cycle plan with roles, activities, interfaces, and required records
- Apply software risk management aligned with ISO 14971 and safety classification
- Establish requirements, architecture, and verification traceability end-to-end
- Implement configuration, change, and problem resolution controls that scale
- Prepare for regulatory submissions and notified body audits with confidence
- Embed security by design so cybersecurity risks are identified, mitigated, and monitored
Audience
- Software Engineers and Architects
- Quality Assurance and Test Engineers
- Regulatory Affairs and Compliance Specialists
- Product Managers and Systems Engineers
- Clinical Software and DevOps Leads
- Cybersecurity Professionals
Course Modules
Module 1 – Standard Scope and Concepts
- Purpose, scope, and definitions
- Safety classes A, B, C
- Relationship to ISO 14971
- Software item and system views
- Lifecycle processes overview
- Essential records and evidence
Module 2 – Planning and Governance
- Software development plan structure
- Roles, responsibilities, competencies
- Supplier and SOUP control strategy
- Tailoring and justification methods
- Interfaces to QMS processes
- Audit readiness from day one
Module 3 – Requirements and Architecture
- Eliciting software requirements
- Safety and security requirements
- Traceability model and IDs
- Architecture viewpoints and styles
- Interface and data specifications
- Design reviews and approvals
Module 4 – Implementation and Verification
- Coding standards and static analysis
- Unit verification strategies
- Integration planning and staging
- Test protocols and acceptance criteria
- Tool validation and documentation
- Defect logging and resolution
Module 5 – Risk and Problem Resolution
- Hazard analysis and risk controls
- Linking faults to mitigations
- Anomaly management workflow
- Change impact assessment
- Post-market surveillance signals
- Field corrective action records
Module 6 – Release and Maintenance
- Release readiness checklist
- Configuration identification/baselining
- Cybersecurity updates and patches
- Vulnerability handling processes
- Legacy software risk re-evaluation
- Continuous improvement metrics
Build devices that clinicians trust and regulators approve. Enroll in IEC 62304 — Software Life Cycle Processes for Medical Devices Fundamentals Training by Tonex to transform your team’s development workflow into a compliant, secure, and audit-ready engine for innovation.