Clinical Evaluation of Medical Devices: an Introduction
Course Description:
This course provides a base-level review of the product validation process from pre to full medical device clinical evaluations. It outlines how to integrate the validation activities into the risk management process and link them to post-market surveillance.
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Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Plan a pre-clinical and clinical validation
- Determine how the activities involved in the validation process will be included in the overall business strategy for a given product
- Understand the clinical investigation requirements necessary for communicating with regulators and clinical professionals
Who Should Enroll:
Professionals new to the medical device industry, including inventors, managers, CEOs, or professionals wanting an overview of the global lifecycle of medical devices are all welcome to enroll in this course.
Prerequisite Knowledge/Requirements:
The following courses are required:
- The Lifecycle of Medical Devices from Idea to Market (ID 159)
- Creating Value in Healthcare (ID 175)
- What is considered a Medical Device? (ID 161)
- The Main Concepts for Safe and Performing Devices (ID 163)
- Business Plan Essentials for Medical Products (ID 177)
- Overview of the Medical Device Design and Development Process (ID 164)