Medical Software and Usability Track: IEC 62304, IEC 62366-1, IEC 82304-1, Agile Medical Software Fundamentals Training by Tonex
Modern medical software must be safe, usable, and auditable—across devices, platforms, and clinical contexts. This course builds practical fluency with IEC 62304 for software life cycle, IEC 62366-1 for usability engineering, and IEC 82304-1 for health software product safety and quality, integrated with agile practices that actually work in regulated environments. You will connect requirements to verification, risk controls to usability, and change management to real release pipelines. Security is inseparable from safety in healthcare: we highlight threat-aware design, secure coding, and postmarket vigilance. You will learn how cybersecurity risks can escalate to clinical hazards and how to prevent them.
Learning Objectives
- Apply IEC 62304 processes to plan, develop, verify, and maintain medical software with traceable artifacts
- Implement IEC 62366-1 usability engineering to reduce use errors and measurable use-related risk
- Align IEC 82304-1 product requirements with quality, safety, and clinical performance claims
- Integrate agile work items, DoD/DoR, and sprints without breaking regulatory rigor
- Build risk management that links hazards, sequences, controls, and verification evidence
- Strengthen cybersecurity in design and postmarket surveillance with threat modeling and secure coding practices
- Create audit-ready documentation that stays current as the product evolves
Audience
- Medical device software engineers
- Systems and quality engineers
- Clinical product owners and business analysts
- Regulatory and compliance professionals
- UX and human factors specialists
- Cybersecurity Professionals
- Engineering managers and technical leads
Course Modules
Module 1 – IEC 62304 Foundations
- Software safety classification basics
- Life cycle planning and tailoring
- Requirements and architecture linkage
- Verification and validation workflow
- Maintenance and change control
- SOUP and supplier oversight
Module 2 – IEC 62366-1 Usability Engineering
- Intended use and user profiles
- Use scenarios and task analysis
- Use error hazard identification
- Formative evaluation techniques
- Summative validation planning
- Residual risk and labeling
Module 3 – IEC 82304-1 Product Focus
- Health software product scope
- Safety and quality requirements
- Clinical performance claims mapping
- Product validation and release criteria
- Documentation set and evidence
- Postmarket responsibilities
Module 4 – Agile in Regulated Contexts
- Agile roles and responsibilities
- User stories with acceptance criteria
- DoR, DoD, and compliance enablers
- Incremental verification strategy
- Traceability within agile tools
- Sprint reviews with evidence
Module 5 – Risk, Safety, and Security
- ISO 14971 risk integration
- Hazard analysis and fault trees
- Threat modeling in clinical context
- Secure coding and dependency hygiene
- Penetration findings to safety cases
- Postmarket cybersecurity monitoring
Module 6 – Documentation and Audits
- Plans, procedures, and templates
- Requirements to test trace matrix
- Objective evidence collection tactics
- Supplier and SOUP documentation
- Audit readiness and mock audits
- Continuous improvement loops
Elevate your team’s confidence shipping safe, usable, and secure medical software. Enroll now with Tonex to master IEC 62304, IEC 62366-1, IEC 82304-1, and agile execution that stands up to clinical reality and regulator scrutiny.