Introduction to Medical Device and Clinical Investigation Planning
Course Description:
This course provides a comprehensive overview of what exactly medical devices are and how they are classified. It explores the stages involved in medical device clinical investigations and how to understand clinical investigation plan objectives in terms of safety, performance, and effectiveness.
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Comprehend the basic EU and US regulatory backgrounds for medical device clinical investigations
- Distinguish major medical device classification systems in investigator brochures
- Illustrate the major stages of medical device development
- Explain and apply safety, performance, and effectiveness objectives to clinical investigation plans
Who Should Enroll:
Monitors or clinical research associates, clinical project managers, investigators, study coordinators, and monitors from the pharmaceutical industry needing to understand the basic medical device regulatory environment are welcome to enroll in this course.
Prerequisite Knowledge/Requirements:
A strong understanding of the basics of good clinical practice is required for this course.