ISO 14155:2026 is the international Good Clinical Practice standard for clinical investigations of medical devices involving human participants. Published in March 2026, it replaces ISO 14155:2020 and reflects current expectations for the ethical and scientific conduct of medical device clinical investigations.
Our online ISO 14155:2026 training course explains what the standard requires and, importantly, what those requirements mean in practice.
You will explore how ISO 14155 applies across the complete clinical investigation lifecycle; from initial planning, study design and informed consent to monitoring, data management, safety reporting and study close-out.
The course also covers important developments within the 2026 edition, including its increased focus on continuous risk management, study governance, participant protection and the quality and reliability of clinical data.
Rather than simply repeating the wording of the standard, we use practical explanations, realistic examples and knowledge checks to help you confidently apply what you have learned in a real clinical research environment.