Training Features

Gap Assessment: ISO 14155:2020 vs 2026​

Stay ahead of regulatory change with a clear, practical overview of ISO 14155:2026 and what it means for your clinical investigations.
Format

E-Learning

Level

Intermediate

Trainer

Malou van Loon

Exam

Exam and certificate included

Duration

30 minutes
3 modules

Price

€ 25 or equivalent currency

Master the Key Updates in ISO 14155:2026

The upcoming ISO 14155:2026 standard introduces important clarifications and enhancements for the planning, conduct, and reporting of clinical investigations for medical devices.

This focused e-learning course guides you through the most relevant updates compared to ISO 14155:2020, helping you understand what has changed, what remains the same, and how to apply these updates in practice. Designed for busy MedTech professionals, this training translates regulatory updates into clear, actionable insights you can immediately use in your daily work.
What You Will Learn
Who Should Attend?
What is Included?
Course Details
By the end of this course, you will be able to:
  • Understand the key differences between ISO 14155:2020 and 2026
  • Distinguish between device-related risks and procedure-related risks
  • Apply a risk-based approach to clinical investigations
  • Interpret updated requirements for adverse event classification
  • Understand the role of estimands in clinical investigation design
  • Identify new expectations for risk management, documentation, and study conduct
  • Recognize updates related to Ethics Committees, informed consent, and oversight bodies.
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • Concise, expert-led video module with a clear explanation of key changes and their practical impact
  • A final quiz to test your knowledge
  • A training certificate upon completion of the training.
Access to any mentioned guidances or ISO standards that are not publicly available is not included in this e-learning.
  • Format: On-demand e-learning
  • Level: Intermediate
  • Duration: Approx. 30-45 minutes
  • Assessment: Final multiple-choice quiz
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
This course is ideal for professionals involved in clinical investigations of medical devices, including:
  • Regulatory Affairs professionals
  • Clinical Affairs specialists
  • Clinical Project Managers
  • Quality Assurance professionals
  • Medical Writers
  • CRO professionals and study sponsors.
Whether you are directly managing studies or supporting them, this course ensures you stay aligned with the latest expectations.

Comprehensive Regulatory Expertise

Advance your career by mastering the standards that define global medical device compliance, all through a flexible learning schedule.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

We offer a flexible learning schedule, allowing professionals to balance their training with their busy work and personal lives, ensuring accessibility to a wide range of learners.

Flexible Learning Schedule

Modules

Explore the training modules available in this course

Meet the Trainer

Malou van Loon

Malou van Loon is a Netherlands-based Certified Clinical Research Associate at Qserve Group, with a background in Clinical Trial support within university hospital settings and expertise in neurodegenerative diseases, urology, and tissue engineering, holding a Master’s degree in Medical Biology from Radboud University.