IEC 81001-5-1 (Mandatory for EU as of 2024–2025) Essentials Training by Tonex
Designed for medical device and health-software teams, this course builds practical fluency in IEC 81001-5-1 as it becomes the default EU cybersecurity baseline. Participants learn what the standard requires, how to operationalize it across product lifecycles, and how to streamline evidence for notified-body review. Strong cybersecurity practices are woven into every activity, from requirements to release. You will understand how resilient architectures, secure coding, and risk controls reduce real-world exploitation paths. The result is faster conformity decisions, fewer late-stage surprises, and safer digital health products that can be defended against evolving threats.
Learning Objectives
- Explain IEC 81001-5-1 scope, structure, and key terms
- Translate requirements into actionable development controls
- Map IEC 81001-5-1 with IEC 62304 and ISO 14971
- Build maintainable secure SDLC practices and metrics
- Prepare audit-ready documentation and objective evidence
- Strengthen cybersecurity posture across the lifecycle, using measurable safeguards that raise security baselines without slowing delivery
Audience
- Product Managers and Owners
- Software Engineers and Architects
- Quality and Regulatory Affairs Professionals
- Risk Managers and Compliance Leads
- Clinical and Health IT Stakeholders
- Cybersecurity Professionals
Course Modules
Module 1 – Standard Overview
- Purpose, scope, and applicability
- Definitions and terminology alignment
- Core clauses and intent
- Relationship to MDR obligations
- Safety–security co-engineering
- Evidence types and conformity paths
Module 2 – Governance and Risk
- Roles, accountability, and RACI
- Security risk management with ISO 14971
- Threat modeling for health software
- Risk acceptance and residual risk
- Metrics and management reviews
- Supplier and third-party oversight
Module 3 – Secure Development
- Secure SDLC policies and gates
- Requirements and misuse cases
- Secure coding standards and checklists
- Code review and static analysis
- Vulnerability management workflow
- Secure build and release practices
Module 4 – IEC 62304 Mapping
- Process alignment across clauses
- Work products and traceability
- Safety classes vs security criticality
- Verification and validation synergy
- Change control and configuration
- Field data feedback into SDLC
Module 5 – Documentation Templates
- Security plan and SDP content
- Risk file and threat model records
- Secure coding guidelines package
- Verification protocol and reports
- SBOM, SOUP, and supplier files
- Postmarket surveillance dossier
Module 6 – Compliance Readiness
- Audit preparation and narratives
- Objective evidence organization
- Nonconformity handling tactics
- Continuous improvement cycles
- Training, competence, and records
- Roadmap for multi-standard harmony
Ready to operationalize IEC 81001-5-1 with confidence and speed Join Tonex to equip your teams with clear methods, reusable templates, and defensible evidence so your next audit feels like confirmation—not discovery.