Introduction to Medical Device and Clinical Investigation Planning
Introduction to Medical Device and Clinical Investigation Planning
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.
ID: 43
45 minutes
2 modules
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
A strong understanding of the basics of good clinical practice is required for this course.
General Requirements for WMDO Courses
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Course Access Duration: Each course is available for 60 days from the date of assignment.
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Quiz Completion: Users are allowed 2 attempts to complete each quiz, with a minimum passing score of 75%.