.svg)
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.
Designed for busy professionals, this course provides a clear, structured overview so you can quickly understand how medical device trials are designed, run, and monitored — ano what is expected from CRAs, project teams, and site personnel working in this environment.
If you are transitional into a medical device company, supporting device studies for the first time, or simply expanding your expertise across clinical research pathwavs. this course gives you the foundational knowledge needed to operate confidently in medical device clinical trials.
.webp)
Kim is an experienced clinical research leader with extensive hands-on expertise particularly in medical device companies. She has held senior operational roles across sponsors, vendors, and CRO environments. includina positions such as Director of Clinical Research, Director of Clinical Operations, Senior Clinical Project Manager, and Senior Clinical Trial Leader.
With over a decade of experience at Johnson & Johnson and leadership roles at both global CROs and medical device companies. Kim has manages complex device and combination product studies across multiple regions. Her background includes trial design, site management regulatory oversight, qualitv assurance, and end-to-end operational execution. Kim brings a uniquely practical perspective to medical device trials - grounded in real-world operational challenges, global regulatory expectations. and the day-to-day realities faced by CRAs and study teams. Her mission is to help clinical research professionals understand the device landscape and feel confident navigating the fundamental differences between device and pharmaceutical trials.
.png)
