Description
Medical Device Trials is an online eLearning course that provides an overview of medical device development, regulation, and clinical trials across the product lifecycle.
It covers device classification, design controls, global regulatory pathways, and key regulatory requirements. Learners explore IDE requirements, ethical oversight, and sponsor and investigator responsibilities.
The course examines essential trial design considerations, including pilot and pivotal studies, controls, endpoints, randomization, and sample size. It also addresses Clinical Investigation Plans, safety monitoring, DSMBs, and study monitoring. Overall, the course builds an understanding of the regulatory, clinical, and post-market requirements governing medical device trials.
The program is made up of 1 module, 3 topics and 4 Quizzes.
On completing your enrolment for the program you will instantly get access to our online learning portal.
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