Foundations of Medical Device Clinical Trials

A rapid introduction to medical device clinical trials - designed for CRAs and clinical operations professionals who want to enter the medical device industry. Medical device studies operate under a different regulatory framework, follow different standards, and require a distinct mindset compared to pharmaceutical studies. This introductory course gives you the essential foundations you need to navigate that world with confidence. Across a series of concise lessons, you'll learn the fundamentals of medical devices, how they're classified, the regulatory landscape governing device studies, ISO 14155 and GCP for medical devices, the unique monitoring requirements, device accountability, safety reporting, and the practical differences between drug and device trials.
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one-time purchase

Course content

8 sections | 14 lessons