Regulation and Clinical Evaluation of Medical Devices (classroom and Asynchronous E-Learning)

On successful completion of this course, you will be able to describe the regulatory concepts and major frameworks governing the development and regulatory management of medical devices and technology, list the key regulatory guidance and requirements, and articulate the important considerations for assessing the clinical performance of medical devices and technology.

What You'll Learn

Health products cover a wide spectrum of modalities, ranging from pharmaceuticals, biologics to medical technology. The regulatory frameworks and requirements differ between medical technology and the others. This course describes the unique approaches for the product design and development, as well as regulation of medical devices and technology. Key concepts for assessing the clinical performance of medical devices will be introduced, facilitating the understanding of an optimal environment for health technology adoption.

Minimum Entry Requirement

Bachelor's degree, basic understanding or relevant experience in health products regulation.