This ISO 14155 2026 course provides a practical and comprehensive introduction to ISO 14155:2026, the international standard for Good Clinical Practice (GCP) in medical device clinical investigations. The latest version of the standard was released in March 2026 and reflects current expectations for the design, conduct, and oversight of clinical investigations.
It is designed for clinical, regulatory, and quality professionals who need to understand how to plan, conduct, and oversee clinical investigations in line with global requirements.
You will learn how to apply the requirements of ISO 14155 across the full lifecycle of a clinical investigation, from study design and informed consent through to monitoring, safety reporting, and study close-out. The course also highlights what has changed in the 2026 update, including the increased focus on continuous risk management, governance, and data quality.
Content is structured in a clear, practical way to support real-world application, helping you move beyond theory and understand how to implement the standard effectively within your organisation.
By the end of the course, you will be able to interpret ISO 14155:2026 requirements, identify key compliance expectations, and apply Good Clinical Practice principles to ensure participant safety and reliable clinical data.
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