What you'll learn:
- What is a medical device, scope and regulatory framework of ISO 14155
- Understand essential Safety and Clinical Definitions in ISO 14155
- Identify and understand the ISO 14155 GCP requirements throughout the planning and conduct of clinical investigations with medical devices
- Learn the core principles of ISO 14155 GCP
- Define the roles and responsibilities of each involved key stakeholder: Ethics Committees, Sponsors and Investigators
- Review the main findings at the sites and sponsors of audits and inspections of clinical investigations
- Reflect upon ISO 14155 GCP deviations as a Sponsor and/or Investigator
Update February 2026: Added Role play exercises
Welcome to this complete edition of the ISO 14155 GCP course on Clinical Investigations with Medical Device!
This course offers the first professional, detailed course for Investigators, Study Coordinators, Sponsors, Clinical Project Managers, Monitors and any other Clinical Study staff requiring knowledge in GCP for a successful execution your clinical trials with Medical Devices. This GCP course is maintained up-to-date with upcoming revisions as they become available.
My name is Dr. Vincent Baeyens PhD, Ihave more than 20 years of experience in running Clinical Trials in Global and mid-size Pharma, and Biotech settings. I have worked with most of the Global as well as several niche CROs andI am also an expert inCRO Management and Oversight, budgeting and Risk Management.
In this course, you will be able to understand ISO GCPrequirements to plan, conduct, clinical trials with Medical Devices in humans. We will review the role and responsibilities of the key stakeholders.
To facilitate the learning of beginner students, the course has been broken up on purpose in several small lectures.
This course will provide you with a strong support to prepare for successful regulatory GCP inspections and audits.
I will lead you step-by-step through the ISO 14155 GCP, and you will learn and understand:
What is a Medical Device
Regulatory framework of ISO 14155
Common ISO GCP audit and inspection findings in clinical investigations (sponsor/investigator)
Scope of ISO 14155
ISO 14155 Good Clinical Practice principles
The responsibilities of ethics committees, principle investigators and sponsor
How to effectively plan a Clinical Investigation
What are the key steps to conduct a Clinical Investigation
What to focus upon in order to be audit and inspection-ready
Reflect upon potential deviations to ISO 14155 GCPs and possible action plan
Please note that, for copyright reasons, I am not allowed to share the copy of the ISO 14155 norm.
A final Quiz at the end of the course will consolidate your knowledge.
Feel free to look at the content of the course to know more and contact me any time if you have any questions!
I am of course available personally during the course as well to answer your questions or comments!
I am looking forward to seeing you inside the course!
Sincerely,
Vincent
