IEC 82304-1 — Health Software Safety and Security Fundamentals Training by Tonex
Modern health software must earn trust across clinical, regulatory, and operational settings. This concise program grounds participants in IEC 82304-1, showing how to specify, develop, validate, and maintain safe, secure health software at scale. You will translate standard clauses into practical lifecycle controls that work with agile, DevOps, and supplier ecosystems.
Cybersecurity remains central: we connect security risk to clinical harm, demonstrate threat-informed controls aligned to IEC 82304-1, and link them to vulnerability handling and post-market surveillance. You will learn to justify safety cases, document conformity, and defend design decisions to auditors—while reducing rework, recalls, and patient risk.
Learning Objectives:
- Interpret IEC 82304-1 scope, terms, and structure
- Map lifecycle processes to quality management systems
- Build a defensible clinical safety case and traceability
- Perform risk analysis tying hazards to software architecture
- Operationalize supplier, data, and usability requirements
- Apply verification, validation, and evidence collection strategies
- Embed cybersecurity risk thinking into safety decisions and documentation
Audience:
- Cybersecurity Professionals
- Medical Device and Health IT Engineers
- Software Architects and Developers
- Quality and Regulatory Affairs Specialists
- Clinical Safety Officers and Risk Managers
- Product Managers and Technical Program Managers
- Compliance, Audit, and Assurance Leads
- Healthcare IT Integrators and Vendors
Course Modules:
Module 1 — Standard Scope and Definitions
- Purpose, scope, and key terms
- Relationship to IEC 62304/ISO 14971
- System-of-interest and boundaries
- Intended use and user profiles
- Safety, security, and quality linkages
- Conformity demonstration overview
Module 2 — Lifecycle and Governance
- Policy, roles, and responsibilities
- Quality management interactions
- Planning and lifecycle tailoring
- Design controls and change control
- Documentation sets and records
- Evidence management strategy
Module 3 — Risk Management Essentials
- Hazard identification techniques
- Clinical harm and risk estimation
- Risk control options and selection
- Residual risk and benefit–risk
- Traceability from hazard to test
- Risk file maintenance practices
Module 4 — Cybersecurity Integration
- Threat modeling for health software
- Secure design and architecture patterns
- Authentication, authorization, and logging
- Secure coding and third-party components
- Vulnerability handling and patching
- Security monitoring and incident response
Module 5 — Verification and Validation
- Test strategy and coverage rationale
- Requirements-to-test traceability
- Usability and human factors checks
- Interoperability and data integrity tests
- Performance, reliability, and robustness
- Acceptance criteria and release readiness
Module 6 — Safety Case and Post-Market
- Safety case structure and arguments
- Objective evidence and confidence levels
- Post-market surveillance planning
- Complaint, CAPA, and recall readiness
- Updates, changes, and re-assessment
- Audit preparation and regulator dialogue
Advance your team’s mastery of IEC 82304-1 and reduce compliance risk while improving product safety and security. Enroll your group with Tonex today to tailor this course to your lifecycle, suppliers, and regulatory targets—and ship trustworthy health software with confidence.