Software Development and IEC 62304 Fundamentals Training by Tonex
Engineers and technical leaders gain a clear, actionable path for building safe, reliable, and compliant medical device software under IEC 62304. You’ll translate the standard’s intent into day-to-day engineering practices—from safety classification to verification and release.
Because medical software is increasingly connected, the course weaves security into lifecycle controls so safety isn’t compromised by exploitable code or weak dependencies. Expect concrete guidance on secure SDLC activities, threat-aware testing, and supplier oversight that reduces exposure across the product and ecosystem. The outcome is a team ready to deliver compliant software that is robust, testable, and defensible during audits and post-market scrutiny.
Learning Objectives:
- Apply IEC 62304 safety classification to architecture, testing, and documentation.
- Structure software architecture, interfaces, and data flows to meet traceability requirements.
- Plan verification and validation with risk-based test strategies and objective evidence.
- Implement configuration and change control across code, tools, and third-party components.
- Align Agile ceremonies and artifacts with IEC 62304 lifecycle deliverables.
- Build supplier and SOUP governance, including SBOMs and evidentiary records.
- Strengthen cybersecurity posture by integrating threat modeling, secure coding, and vulnerability management within the compliant lifecycle.
Audience:
- Software Engineers and Architects
- Systems and Quality Engineers
- Regulatory and Compliance Managers
- Product Owners and Project Managers
- Test/Verification Engineers
- Clinical/Biomedical Engineers
- Cybersecurity Professionals
Course Modules:
Module 1: Safety Classification Essentials
- Class A/B/C determination
- Hazard/risk linkage
- Risk controls in software
- Safety requirements derivation
- Evidence expectations per class
- Common misclassification pitfalls
Module 2: Compliant Architecture Design
- Layered and modular design
- Interface and data contracts
- Traceability to hazards
- Defensive design patterns
- Error handling strategies
- Real-time and resource limits
Module 3: Verification and Validation Strategy
- Test planning by safety class
- Unit and integration coverage
- Interface and fault injection tests
- Requirements-to-test traceability
- Objective evidence and results
- Anomaly tracking and closure
Module 4: Configuration and Change Control
- Baselines and versioning rules
- Branching and release discipline
- Tool qualification basics
- SOUP and dependency control
- SBOM generation and upkeep
- Change impact assessment
Module 5: Agile Methods in Compliance
- DoD/DoR tied to evidence
- User stories with safety hooks
- Definition of “Done” for tests
- Incremental risk re-evaluation
- Sprint reviews for auditors
- Retrospectives improving controls
Module 6: Secure SDLC Integration
- Threat modeling for devices
- Secure coding checklists
- Static and dynamic analysis
- Vulnerability disclosure flows
- Patch and update governance
- Post-market monitoring cues
Elevate your team’s confidence with a practical, audit-ready IEC 62304 approach that embeds security and safety from concept to release. Enroll your group with Tonex to tailor this program to your device class, development tooling, and regulatory pathway.