ISO 14155 — Clinical Investigation of Medical Devices for Human Subjects Essentials Training by Tonex
Navigate ISO 14155 with confidence, from study planning to closeout, while aligning ethics, science, and quality. This program clarifies sponsor responsibilities, investigator duties, monitoring strategies, and documentation rigor to protect subjects and generate credible evidence.
Modern devices increasingly embed software and connectivity, making threat surfaces part of safety profiles. We address data integrity, secure handling of eCRFs, and protection of PHI to reduce breach risks. You will connect risk management, usability, and post-market learning with secure-by-design practices, so clinical investigations remain compliant, auditable, and resilient.
Learning Objectives
- Explain ISO 14155 purpose, scope, and foundational principles
- Map roles and responsibilities across sponsor, investigator, and CRO
- Develop compliant clinical investigation plans and essential documents
- Design monitoring, safety reporting, and data quality controls
- Integrate human factors and risk management with clinical endpoints
- Strengthen data protection and privacy measures to enhance cybersecurity in connected device trials
- Prepare for audits, inspections, and defensible clinical evidence packages
Audience
- Clinical Affairs Managers
- Regulatory Affairs Specialists
- Quality and Compliance Leaders
- Principal Investigators and Study Coordinators
- Biomedical and Systems Engineers
- Product Managers and R&D Leads
- Cybersecurity Professionals
Program Modules
Module 1 — Foundations and Scope
- Standard structure and key terms
- Ethical principles and declarations
- Risk, benefit, and scientific validity
- Device categories and applicability
- Interactions with ISO 14971
- Harmonization with GCP frameworks
Module 2 — Planning the Investigation
- Clinical evaluation and rationales
- Clinical Investigation Plan essentials
- Endpoints, success criteria, statistics
- Subject selection and eligibility
- Informed consent requirements
- Data management strategy overview
Module 3 — Study Conduct and Oversight
- Investigator obligations and training
- Monitoring approaches and rationales
- Source data verification practices
- Deviations and corrective measures
- Adverse events and SAE handling
- Safety reporting timelines compliance
Module 4 — Data Integrity and Security
- ALCOA principles and audit trails
- eCRF design and validation basics
- Secure transmission and storage
- Privacy, PHI, and de-identification
- Vendor qualification and oversight
- Contingency and continuity planning
Module 5 — Human Factors and Risk
- Usability engineering touchpoints
- Clinical risk controls alignment
- Device software change impacts
- Interface hazards in real use
- Training and competence evidence
- Benefit-risk reassessment gates
Module 6 — Closeout and Submission
- Statistical analysis and reporting
- Clinical investigation report essentials
- Records retention and archiving
- Readiness for audits, inspections
- Post-market surveillance linkages
- Lessons learned to improvement
Elevate your team’s clinical rigor and regulatory confidence with Tonex. Enroll now to master ISO 14155, harden data integrity and cybersecurity practices, and deliver trustworthy evidence for safer, more effective medical devices.