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.
About this course
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, and what is expected from CRAs, project teams, and site personnel working in this environment.
What you will learn
The foundational knowledge needed to operate confidently in medical device clinical trials.
Module 1Course Introduction1 lesson
- Introduction to the course
Module 2Medical Devices: Core Concepts4 lessons
- What is a medical device?
- Medical device definitions
- Medical device classes
- Introduction to IVDs
Module 3Medical Device Regulations2 lessons
- Overview of medical device regulations
- Key regulatory frameworks and authorities
Module 4Standards & GCP for Medical Devices2 lessons
- ISO 14155 overview
- GCP principles applied to medical device trials
Module 5Types of Medical Device Trials2 lessons
- Types of medical device trials
- How device trials differ from drug trials
Module 6Monitoring in Medical Device Trials2 lessons
- Monitoring approaches in device trials
- Considerations when monitoring medical device studies
Module 7Device Accountability & Safety3 lessons
- Device accountability
- Safety reporting in device trials
- Device deficiencies and issue management
Module 8Additional Considerations in Device Trials1 lesson
- Other practical considerations for medical device studies
Who this course is for
Perfect for CRAs who want to understand how device trials differ, what ISO 14155 requires, and how monitoring responsibilities shift in device-focused research.
Ideal for project managers, CTAs, regulatory staff, or site staff preparing to support device submissions, device accountability, safety workflows, and device-specific oversight.
Great for early-career professionals who want a quick, clear introduction to the device landscape, classifications, regulations, and what makes device-based trials unique.
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, including 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 managed complex device and combination product studies across multiple regions. Her background includes trial design, site management, regulatory oversight, quality 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.
Our graduates work at top industry companies
Device trials are different. Learn the difference.
A structured introduction to the regulations, standards and monitoring expectations of medical device research.