Thực hành Lâm sàng Tốt ISO 14155 cho Thiết bị Y tế

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, I have 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 and I am also an expert in CRO Management and Oversight, budgeting and Risk Management. 

In this course, you will be able to understand ISO GCP requirements 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