This course 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.

Indian students: Choose the Offline Payment option at Checkout. Once your Order is created you will receive an email with a link to complete your payment of INR 19,999.