Clinical Investigations with Medical Devices: ISO 14155 Good Clinical Practice (GCP) Basic Course
Clinical Investigations with Medical Devices in Accordance with the MDR and the Medical Devices Law Implementation Act (MPDG)
Clinical investigations are a critical component of demonstrating the safety, performance, and clinical benefit of medical devices throughout their lifecycle. ISO 14155 establishes the internationally recognized Good Clinical Practice (GCP) requirements for the design, conduct, recording, and reporting of clinical investigations involving human subjects.
This foundational course provides a practical introduction to ISO 14155 and its application within the medical device regulatory environment. Participants will gain an understanding of clinical investigation planning, documentation, ethics and regulatory requirements, study conduct, safety reporting, and reporting obligations under the Medical Device Regulation (MDR).
Upon completion of this course, you will be able to:
- Explain the purpose and scope of ISO 14155
- Describe the relationship between ISO 14155, MDR, Declaration of Helsinki, GDPR, and related guidance documents.
- Differentiate between various types of clinical investigations and PMCF studies.
- Explain the stages of clinical development for medical devices.
- Identify sponsor, investigator, and ethics committee responsibilities.
- Understand the requirements for planning and designing clinical investigations.
- Describe essential study documentation, including CIP, IB, CRF, and informed consent documents.
- Explain requirements for subject protection and ethical conduct.
- Describe approval pathways involving competent authorities and ethics committees.
- Understand monitoring, data management, and safety reporting requirements.
- Explain clinical investigation reporting and study close-out requirements.
- Apply Good Clinical Practice principles throughout the clinical investigation lifecycle.
This course is intended for professionals involved in medical device clinical research, development, and regulatory compliance, including:
- Clinical Affairs Professionals
- Clinical Research Professionals
- Clinical Project Managers
- Clinical Trial Managers
- Clinical Study Coordinators
- Study Nurses
- Regulatory Affairs Professionals
- Quality Assurance Professionals
- Medical Device Manufacturers
- Product Development Teams
- Medical Device Consultants
- CRO Personnel
- Clinical Investigation Service Providers
- Principal Investigators and Sub-Investigators
- Medical Device Start-up Teams
- Regulatory Authorities and Healthcare Professionals involved in clinical research
Module 1: Introduction to Clinical Investigations
- Importance of clinical investigations under MDR
- Clinical evidence and clinical evaluation
- Definition and purpose of clinical investigations
- Clinical benefit, safety, and performance concepts
- Clinical development planning
Module 2: Regulatory Framework and Good Clinical Practice
- Overview of ISO 14155
- EU Medical Device Regulation (MDR)
- Declaration of Helsinki
- GDPR considerations
- MDCG guidance documents
- National regulatory considerations
Module 3: Types and Categorization of Clinical Investigations
- Exploratory and pilot studies
- First-in-human and feasibility studies
- Pivotal clinical investigations
- Post-market clinical investigations
- PMCF studies
- Other clinical investigations under MDR Article 82
Module 4: Planning a Clinical Investigation
- Study objectives and endpoints
- Study design considerations
- Risk-benefit analysis
- Risk management
- Sample size and subject selection
- Vulnerable populations
Module 5: Essential Clinical Investigation Documentation
- Clinical Investigation Plan (CIP)
- Investigator's Brochure (IB)
- Case Report Forms (CRF)
- Subject information and informed consent
- Data protection documentation
- Device accountability documentation
Module 6: Roles and Responsibilities
- Sponsor responsibilities
- Principal Investigator responsibilities
- Clinical investigation site requirements
- Investigator qualifications
- Site selection and suitability
Module 7: Approval and Conduct of Clinical Investigations
- Ethics committee review
- Competent authority interactions
- Clinical investigation applications
- Study initiation and conduct
- Monitoring and data management
Module 8: Safety Reporting and Vigilance
- Adverse events (AEs)
- Serious adverse events (SAEs)
- Device deficiencies
- Sponsor reporting obligations
- Investigator reporting obligations
Module 9: Study Close-Out and Reporting
- Clinical Investigation Reports
- Summary reports
- Study completion requirements
- Archiving requirements
- Integration into clinical evaluation and PMCF activities
Module 10: Knowledge Check
- Interactive quiz
- Practical discussions
- Q&A session
Clinical investigations have become increasingly important under the European Medical Device Regulation (EU MDR 2017/745), requiring manufacturers to generate robust clinical evidence demonstrating the safety, clinical performance, and clinical benefit of their medical devices. ISO 14155:2020 serves as the internationally accepted Good Clinical Practice standard governing the conduct of clinical investigations involving human subjects.
This course provides a comprehensive introduction to the principles and requirements of ISO 14155 and explains how Good Clinical Practice supports the generation of reliable and scientifically valid clinical data throughout the medical device lifecycle. Participants will gain insight into how clinical investigations fit within clinical development strategies, clinical evaluation activities, and post-market clinical follow-up programs.
The training covers the complete clinical investigation lifecycle, including study planning, risk assessment, development of essential study documentation, ethics and regulatory approvals, site selection, informed consent, study execution, monitoring, safety reporting, data management, clinical investigation reporting, and archiving requirements.
The course also explains the relationship between ISO 14155, the European MDR, the Declaration of Helsinki, GDPR requirements, and relevant MDCG guidance documents. Participants will learn the respective responsibilities of sponsors, investigators, ethics committees, and regulatory authorities involved in clinical investigations.
Through practical examples, case discussions, exercises, and knowledge checks, participants will develop a solid understanding of Good Clinical Practice requirements and gain practical knowledge that can be immediately applied to clinical affairs, regulatory affairs, quality management, and medical device development activities.
You will be able to:
- Understand the purpose and application of ISO 14155 Good Clinical Practice requirements
- Learn how clinical investigations support clinical evidence generation under MDR
- Understand the different categories of clinical investigations and PMCF studies
- Gain knowledge of sponsor and investigator responsibilities
- Understand ethics committee and regulatory authority approval processes
- Learn how to prepare essential clinical investigation documentation
- Understand informed consent, subject protection, and ethical considerations
- Gain knowledge of risk management and risk-benefit assessment in clinical investigations
- Learn safety reporting and vigilance requirements
- Improve their ability to contribute to clinical investigation planning and management activities
- Learn from experienced TÜV SÜD medical device experts
- Network with peers from clinical, regulatory, and quality functions
This instructor-led live virtual training combines theory with practical application through:
- Expert-led presentations
- Interactive discussions
- Real-world examples
- Case studies
- Knowledge checks and quizzes
- Group exercises
- Question-and-answer sessions
- Practical interpretation of regulatory and ISO requirements
Participants engage directly with the instructor and peers through a virtual classroom environment.
Participants who attend at least 90% of the total training duration will receive a Certificate of Attendance from TÜV SÜD Academy upon completion of the training.
Participants must provide their own copy of ISO 14155 for this course. Participants can obtain a copy of the standard at ISO Store online.
- No prior knowledge of ISO 14155 is required.
- A basic understanding of medical devices, quality management systems, regulatory affairs, clinical affairs, or clinical research is beneficial but not mandatory.
- Participants should obtain access to their own copy of ISO 14155, as the standard may be referenced throughout the course.
Learning Path:
- This course is part of a modular training programme. After successful participation in the advanced modules, you can acquire this recognized qualification:
- Manager Clinical Affairs – TÜV
- Included in the course price is the eBook "Medical Device Regulation (MDR)".
What is ISO 14155?
ISO 14155 is the international Good Clinical Practice (GCP) standard that defines requirements for the design, conduct, recording, monitoring, auditing, and reporting of clinical investigations involving human subjects and medical devices.
Is this course focused on medical devices or pharmaceuticals?
This course focuses exclusively on medical device clinical investigations and the requirements of ISO 14155 and MDR.
Does the course cover the European MDR?
Yes. The course explains how ISO 14155 supports compliance with the EU Medical Device Regulation (MDR 2017/745).
Will I learn how to plan a clinical investigation?
Yes. The course covers clinical investigation planning, study design, endpoints, risk-benefit assessment, and documentation requirements.
Does the course address ethics committee and regulatory approval requirements?
Yes. Participants learn about interactions with ethics committees, competent authorities, approval pathways, and submission requirements.
Are sponsor and investigator responsibilities covered?
Yes. The course explains the specific responsibilities of sponsors, investigators, and other parties involved in clinical investigations.
Does the training include post-market clinical follow-up (PMCF)?
Yes. PMCF studies and their role in generating post-market clinical evidence are covered.
Will I learn about informed consent requirements?
Yes. The course reviews informed consent, subject protection, privacy requirements, and ethical principles.
Does the course address safety reporting?
Yes. Participants learn about adverse events, serious adverse events, device deficiencies, vigilance reporting, and safety monitoring.
Is prior clinical research experience required?
No. This is a foundational course designed for individuals new to clinical investigations as well as professionals seeking structured ISO 14155 knowledge.
What training format is used?
The course is delivered as a live instructor-led virtual training with opportunities for interaction, discussions, exercises, and questions.
Is the course suitable for Regulatory Affairs professionals?
Yes. Regulatory affairs, clinical affairs, quality professionals, project managers, and medical device manufacturers will all benefit from the training.
Does the course include practical examples?
Yes. Real-world examples, case discussions, and practical scenarios are used throughout the training to reinforce learning.
Will participants receive a certificate?
This should be answered according to the specific TÜV SÜD certification model and local Academy offering.
What version of ISO 14155 is covered?
The course is based primarily on ISO 14155:2020 and discusses relevant updates, guidance documents, and current regulatory expectations.
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