ISO 14155:2026 Good Clinical Practice for Medical Devices

ISO 14155:2026 ONLINE COURSE

Develop a practical understanding of the latest Good Clinical Practice requirements for clinical investigations of medical devices.

Created by clinical research and medical device compliance experts, this online ISO 14155:2026 course explains how to apply the standard throughout the planning, conduct, oversight and reporting of a clinical investigation.

The course is suitable for individual clinical research professionals and organisations requiring consistent, up-to-date ISO 14155:2026 training across their teams.
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Not Enrolled

Price

£129.00

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KEY FEATURES OF OUR ONLINE ISO 14155:2026 TRAINING COURSE:

  • 100% online and available on demand
  • Learn anywhere at your own pace
  • Developed by industry-experienced experts with more than 35 years of clinical research experience
  • Updated for the requirements of ISO 14155:2026
  • Interactive content, practical examples and knowledge checks
  • Certificate awarded upon successful completion
  • Available for individuals and corporate teams
ISO 14155 2026 course Testimonial

Course Content

ISO 14155:2026 Good Clinical Practice for Medical Devices

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PRACTICAL ISO 14155:2026 TRAINING DEVELOPED BY CLINICAL EXPERTS

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.

ISO 14155:2026 TRAINING FOR INDIVIDUALS AND CLINICAL RESEARCH TEAMS

Whether you are completing ISO 14155 training for your own professional development or coordinating training across an international clinical research team, Integrity Clinical Compliance offers a flexible online learning solution.

INDIVIDUAL LEARNERS

Training for individuals

Individual professionals gain immediate online access and can complete the ISO 14155:2026 training at a time, location and pace that suits you.

CORPORATE TEAMS

Corporate training

Our multiple licence options help you provide consistent training across your teams while improving training and simplifying course administration and training oversight.

Get certified. Stay compliant. Advance your career.

Join thousands of professionals who have completed our training.

WHAT WILL I LEARN FROM THIS ISO 14155:2026 TRAINING COURSE?

This online course provides a structured overview of the standard and explains how its requirements apply throughout a medical device clinical investigation.

Understand the key principles and requirements of ISO 14155:2026 and how they apply to the design, conduct, documentation and reporting of medical device clinical investigations.

Apply Good Clinical Practice principles to support participant safety, ethical conduct, informed consent, risk management and reliable clinical data throughout the investigation lifecycle.

Explain the roles and responsibilities of sponsors, investigators and other key stakeholders, including requirements for data management, safety reporting, quality oversight, audits and inspections.

Recognise how ISO 14155:2026 supports regulatory compliance and the generation of robust clinical evidence to demonstrate the safety and performance of medical devices.

FREQUENTLY ASKED QUESTIONS ABOUT ISO 14155:2026 TRAINING

What is ISO 14155:2026?

ISO 14155:2026 is the international standard for Good Clinical Practice in clinical investigations of medical devices involving human participants.

Published in March 2026, it replaces ISO 14155:2020 and establishes requirements for protecting the rights, safety and wellbeing of participants while ensuring that clinical data are credible, reliable and suitable for their intended purpose.

The 2026 edition introduces updated expectations affecting the planning, governance, conduct and reporting of medical device clinical investigations. Important areas include continuous risk management, study design and statistical considerations, Clinical Events Committees, Data Monitoring Committees, informed consent, safety reporting and data quality.

 

Can I complete the ISO 14155:2026 course online?

Yes. This is a fully online, self-paced ISO 14155:2026 course that can be completed wherever and whenever is convenient. There are no fixed classroom dates, making it suitable for individual professionals and teams working across different locations and time zones.

Can organisations purchase multiple ISO 14155:2026 course licences?

Yes. We provide corporate and team licences for organisations of all sizes. These can be used to train employees, contractors, CRO personnel and investigation-site teams using consistent course content.

Corporate options include centralised learner management, progress tracking and completion records. Contact us with your approximate number of learners to receive a tailored quotation.

Will I receive an ISO 14155:2026 certificate?

Yes. Learners receive a certificate after successfully completing the ISO 14155:2026 course. This provides evidence that they have completed training on Good Clinical Practice for medical device clinical investigations.

What makes Integrity Clinical Compliance’s training different?

Our course is written by experienced clinical research professionals, not generated by AI, and is designed to support practical application rather than tick-box learning.

Interactive content, realistic scenarios, practical examples and robust knowledge checks help learners understand how ISO 14155:2026 affects real medical device clinical investigations.

Who should complete ISO 14155 2026 online training?

This course is designed for clinical professionals involved in the planning, conduct, management or oversight of medical device clinical investigations, including:

  • Research professionals
  • Research associates and monitors
  • Project managers
  • Principal investigators and study-site personnel
  • Medical device manufacturers
  • Clinical trial sponsors
  • CRO employees and consultants
  • Regulatory affairs professionals
  • Quality assurance and compliance teams
  • Clinical operations personnel
  • Medical and scientific affairs professionals
  • Clinical data management teams

The course is suitable for professionals new to medical device clinical research and experienced personnel who need to update their knowledge following the publication of ISO 14155:2026.

If this course isn’t right for you, take a look at our other online clinical courses.