ISO 14155: Advanced Conduct of Clinical Investigations for Medical Devices
Practical Implementation of ISO 14155 Good Clinical Practice Requirements for Conducting Compliant Medical Device Clinical Investigations.
This advanced training course provides a practical understanding of how to conduct medical device clinical investigations in accordance with ISO 14155 and applicable regulatory requirements. Building on foundational clinical research knowledge, participants will examine the principles of Good Clinical Practice (GCP) and the operational responsibilities of sponsors, investigators, monitors, and supporting study functions throughout the clinical investigation lifecycle.
The course explores risk management, data integrity, vigilance reporting, quality management, monitoring, auditing, and oversight requirements necessary to protect study participants and ensure reliable clinical evidence. Through practical examples and expert instruction, participants will learn how to implement ISO 14155 requirements effectively and maintain compliance throughout planning, conduct, analysis, reporting, and study closure activities.
Upon completion of this course, participants will be able to:
- Explain the objectives, scope, and regulatory relevance of ISO 14155.
- Apply Good Clinical Practice principles to medical device clinical investigations.
- Define sponsor and investigator responsibilities throughout the investigation lifecycle.
- Establish appropriate quality management and oversight processes.
- Implement risk management activities in accordance with ISO 14155.
- Manage essential study documentation and maintain complete traceability.
- Apply requirements for informed consent, participant protection, and protocol compliance.
- Implement data management processes that support data integrity and regulatory compliance.
- Apply ALCOAC+ principles to clinical investigation documentation and records.
- Understand vigilance reporting requirements and safety event management.
- Develop risk-based monitoring approaches and monitoring plans.
- Support audit readiness and inspection preparedness for medical device studies.
This course is intended for:
- Clinical Affairs Professionals
- Clinical Research Professionals
- Clinical Project Managers
- Regulatory Affairs Professionals
- Medical Device Manufacturers
- Sponsor Organizations
- Principal Investigators and Study Coordinators
- CRO Personnel supporting medical device studies
- Quality Assurance Professionals
- Data Management Professionals
- Product Managers involved in clinical evidence generation
- Start-up organizations assuming sponsor responsibilities
- Consultants supporting medical device clinical investigations
- Service providers conducting or supporting clinical investigations
Module 1: ISO 14155 Fundamentals and Good Clinical Practice Framework
- Scope and objectives of ISO 14155
- Good Clinical Practice principles
- Participant protection and data quality
- Quality management and risk management foundations
- Clinical investigation roles and responsibilities
Module 2: Sponsor and Investigator Responsibilities
- Sponsor obligations and oversight responsibilities
- Manufacturer as sponsor
- Delegation and vendor oversight
- Clinical quality management systems
- Trial Master File (TMF) and Investigator Site File (ISF)
- Documentation control and archiving
- Risk management implementation
- Participant recruitment and informed consent
- Protocol compliance and protocol deviations
- Investigational device accountability
- Participant safety management
Module 3: Data Management and Data Analysis
- Clinical data lifecycle
- Source data and eCRF management
- ALCOAC+ principles
- Database systems and validation requirements
- Data protection and confidentiality
- Data validation and cleaning
- Database lock procedures
- Statistical analysis planning
- Clinical investigation reporting
Module 4: Vigilance Reporting in Clinical Investigations
- Vigilance systems under ISO 14155 and MDR
- AE, SAE, ADE, SADE and device deficiency definitions
- Causality assessment methodologies
- Investigator reporting obligations
- Sponsor reporting obligations
- Regulatory reporting timelines
- Benefit-risk assessment
- Safety trend analysis and signal detection
Module 5: Monitoring, Audits and Quality Assurance
- Monitoring requirements under ISO 14155
- Risk-based monitoring approaches
- Monitoring plans
- On-site and centralized monitoring
- Trigger-based monitoring
- Initiation, routine, and close-out visits
- Monitoring reports
- Quality assurance audits
- Audit planning and execution
- Inspection readiness
Medical device clinical investigations play a critical role in demonstrating the safety, performance, and clinical benefit of medical technologies. ISO 14155 provides the internationally recognized framework for conducting clinical investigations according to Good Clinical Practice (GCP) principles while safeguarding participant rights, safety, and well-being. This advanced course equips participants with the practical knowledge required to implement these requirements in real-world study environments.
Participants will gain a comprehensive understanding of sponsor and investigator responsibilities, including study oversight, quality management, risk management, documentation, informed consent processes, investigational device accountability, protocol compliance, and management of study deviations. The course also examines how manufacturers can effectively fulfill their sponsor obligations while maintaining appropriate oversight of outsourced activities.
A significant portion of the course focuses on data quality and integrity throughout the clinical investigation lifecycle. Participants will learn about source data management, electronic data systems, ALCOAC+ principles, database validation, query management, database lock procedures, statistical analysis planning, and clinical investigation reporting requirements.
The training further addresses the establishment of an effective vigilance framework, including adverse event classification, safety reporting obligations, causality assessment, sponsor reporting responsibilities, regulatory reporting timelines, and benefit-risk evaluation throughout the study lifecycle.
Finally, participants will explore quality assurance activities including risk-based monitoring strategies, monitoring plans, initiation visits, routine monitoring, close-out activities, monitoring reports, audits, and inspection readiness. By the end of the course, participants will be able to apply ISO 14155 requirements in a structured, compliant, and audit-ready manner during medical device clinical investigations.
Participants will be able to:
- Understand the purpose, scope, and application of ISO 14155 for medical device clinical investigations.
- Apply Good Clinical Practice (GCP) principles throughout the clinical investigation lifecycle.
- Understand the roles and responsibilities of sponsors, investigators, monitors, and supporting study functions.
- Develop practical approaches to clinical quality management and oversight.
- Implement risk management principles at both device and study levels.
- Manage essential study documentation including TMFs and ISFs.
- Apply data integrity and ALCOAC+ principles to clinical investigation data.
- Understand requirements for electronic data systems, validation, and database management.
- Establish effective vigilance reporting processes and safety oversight activities.
- Implement risk-based monitoring and quality assurance strategies.
- Prepare for audits, inspections, and regulatory reviews.
- Improve operational compliance with ISO 14155 and applicable medical device regulations.
This instructor-led live virtual training combines expert presentations with practical application exercises designed to reinforce understanding of ISO 14155 requirements.
Learning methods include:
- Expert-led lectures and guided discussions
- Practical examples and real-world case scenarios
- Interactive exercises and group activities
- Knowledge checks and quizzes
- Risk management and monitoring examples
- Regulatory interpretation discussions
- Participant experience sharing and peer learning
The live virtual format allows participants to interact directly with the instructor, ask questions, and discuss implementation challenges while benefiting from collaborative learning with peers from the medical device industry.
Participants who attend at least 90% of the total training duration will receive a Certificate of Attendance from TÜV SÜD Academy.
Participants must provide their own copy of ISO 14155 for this course. Participants can obtain a copy of the standard at ISO Store online.
- Basic knowledge of medical device clinical investigations.
- Familiarity with clinical research terminology and processes.
- Prior attendance of Clinical Testing of Medical Devices – Basic Course or equivalent experience is recommended.
- General awareness of MDR clinical evidence requirements and GCP principles is beneficial but not mandatory.
This course is part of a modular training programme. After successful participation in the advanced courses, you can acquire this recognized qualification: Manager Clinical Affairs – TÜV
Is this a beginner-level course?
No. This is an advanced course intended for professionals who already possess basic knowledge of clinical investigations or have completed an introductory medical device clinical investigations course.
Does the course focus on pharmaceutical clinical trials?
No. The course specifically focuses on medical device clinical investigations conducted under ISO 14155.
Is ISO 14155 covered in detail?
Yes. The training provides an in-depth review of operational ISO 14155 requirements and their practical implementation.
Does the course explain sponsor responsibilities?
Yes. Sponsor responsibilities represent a major component of the training, including oversight, quality management, risk management, documentation, monitoring, and vigilance activities.
Does the course address MDR requirements?
Yes. Regulatory references to the MDR and related clinical investigation requirements are discussed throughout the course.
Will I learn about Trial Master Files (TMF)?
Yes. The course covers TMF structure, documentation requirements, traceability, document control, and archiving activities.
Does the course cover risk management?
Yes. Risk management at both the device and study levels is covered, including risk assessment, risk control measures, and ongoing risk evaluation.
Is vigilance reporting included?
Yes. Participants learn adverse event classification, causality assessment, investigator responsibilities, sponsor responsibilities, and reporting timelines.
Will data management and data integrity be discussed?
Yes. The course includes source data management, ALCOAC+ principles, database systems, data validation, database lock, and reporting practices.
Does the course explain risk-based monitoring?
Yes. Participants learn how to design and implement risk-based monitoring strategies and monitoring plans.
Does the course cover audits and inspections?
Yes. Quality assurance audits, audit planning, monitoring reports, and inspection readiness requirements are addressed.
Do I need a copy of ISO 14155?
Participants are strongly encouraged to have access to their own copy of ISO 14155 to maximize the learning experience.
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