Mastertrial eLearning

Mastertrial eLearning, presented as the "Medtech Training Universe," is an online learning platform focused on medical technology, medical device regulation, and clinical research topics. It is aimed at professionals working in the medtech and life sciences sectors who need to build or update their knowledge of regulatory frameworks, clinical evaluation, and digital health developments.

The platform offers a mix of video courses and video lectures, some of which are available free of charge. Courses are structured to allow learners to progress at their own pace, and several include a certification test upon completion.

Available Course Topics

• Transcatheter Cardiac Occluders – ISO 22679: A complete video course covering the ISO 22679 draft standard for cardiac occluders, positioned under product guidelines and standards. Certified training is available upon completion.
• Clinical Evaluation Upgrade to MDR: A 39-minute video lecture addressing how to prepare a clinical evaluation for compliance with the EU Medical Device Regulation (MDR). Includes a brief test for certification after completion.
• Clinical Trials for Medical Devices in Europe – Complete Training Program: A video course covering new definitions and types of clinical trials, the roles of sponsors, investigators, and subjects, ethical principles, informed consent, coordinated assessment, substantial changes, temporary halts, termination procedures, and adverse event reporting.
• The Virality of Digital Health: A free video lecture in which Peter Fitzgerald presents an overview of the digital health landscape in the context of the COVID era and beyond.
• Digital Health Revolution: A free interview-format video lecture also featuring Peter Fitzgerald, covering developments and trends in digital health.
• FDA Premarket Approval (PMA): A video course providing regulatory information on the FDA Premarket Approval process, part of a broader series on FDA medical device regulation.

Platform Features

• Free registration option available for accessing courses.
• Courses offered in both free and paid formats.
• Certified training available for select courses, with post-course tests to earn certification.
• Self-paced learning format across video courses and video lectures.
• Course search functionality to find specific topics within the catalogue.

The platform is developed in association with Meditrial and covers regulatory, clinical, and digital health subject areas relevant to medtech professionals navigating EU MDR requirements, FDA processes, and emerging digital health trends.