ISO 14155: Clinical Investigation of Medical Devices Essentials Training by Tonex
Built for teams that move fast yet refuse to compromise compliance, this course demystifies ISO 14155 with a practical roadmap from concept to closeout. You’ll learn how to plan, execute, and document ethical, scientifically sound device investigations that withstand regulator scrutiny.
Because connected devices and eCRFs expand attack surfaces, we also highlight secure-by-design documentation, privacy-by-default data flows, and audit-ready controls. Expect guidance on safeguarding PHI/PII, minimizing breach exposure, and aligning clinical workflows with organizational cybersecurity governance for resilient trials and confident submissions.
Learning Objectives
- Translate ISO 14155 principles into day-to-day study operations
- Design protocols, CRFs, and plans that meet regulator expectations
- Apply risk management and safety reporting throughout the study lifecycle
- Strengthen sponsor–CRO–site collaboration and accountability
- Use inspection-ready documentation and traceability practices
- Embed cybersecurity considerations into clinical data handling and monitoring, ensuring robust cybersecurity alignment across devices and eClinical systems
Audience
- Clinical Research Associates (CRAs)
- Clinical Project Managers and Trial Leads
- Quality and Regulatory Affairs Professionals
- Medical Device R&D and Design Engineers
- Data Management and Biostatistics Teams
- Cybersecurity Professionals
Course Modules
Module 1 – ISO 14155 Foundations
- Scope, structure, and key definitions
- Ethical principles and participant rights
- Roles of sponsor, PI, and monitors
- Clinical evidence and device lifecycle
- Documentation hierarchy and control
- Standards landscape and harmonization
Module 2 – Protocol and Planning
- Endpoints, hypotheses, and rationale
- Study design selection and justification
- Inclusion/exclusion and vulnerability safeguards
- Sample size, statistics, and analysis plan
- Source data, CRFs, and eCRF alignment
- Study plans QMS linkage and ownership
Module 3 – Risk and Safety
- ISO 14971 interface and hazard analysis
- Risk control measures and residual risk
- Safety monitoring plan and oversight
- AE/SAE recording and follow-up
- Device deficiencies and reporting paths
- Data Safety Monitoring governance
Module 4 – Ethics and Consent
- EC/IRB submissions and approvals
- Informed consent essentials and readability
- Vulnerable populations protections
- Privacy, confidentiality, and data minimization
- Post-approval changes and re-consent triggers
- Cultural/linguistic adaptation best practices
Module 5 – Data and Monitoring
- Source data verification and traceability
- Monitoring strategies: on-site/remote/risk-based
- Data integrity and ALCOA-plus principles
- EDC controls, audit trails, and queries
- Handling protocol deviations and CAPA
- Interim analyses and data locks
Module 6 – Reporting and Closeout
- Clinical Investigation Report structure
- Investigator’s Brochure updates and alignment
- Device accountability and reconciliation
- Archiving, retention, and access controls
- Inspection readiness and mock audits
- Lessons learned and continuous improvement
Ready to elevate your team’s clinical rigor and regulatory confidence? Enroll your stakeholders in Tonex’s ISO 14155 Essentials today to operationalize compliant, ethical, and security-aware device investigations that accelerate approvals and strengthen patient trust.