Medical Devices: Definition & Lifecycle

This course acts as a primer—a basic introduction to medical devices and general aspects of product and regulatory lifecycles.

Medical devices undergo a long, complex development process before being made available for therapeutic or diagnostic use; this process involves professionals from varied backgrounds, including scientists, clinicians, regulatory specialists, legal experts, and business specialists.

Whether considering a career in medical device development or simply seeking a better understanding of the medical device business, this course lays the foundation for a more in-depth study of medical devices and their regulation by providing an introduction to medical devices, a brief history of medical device regulation, general aspects of product and regulatory lifecycles, and information on basic regulatory principles and concepts as they apply to medical devices.

At a Glance

Target Audience: This course benefits new regulatory and clinical professionals, as well as business and investment professionals looking to learn more about fundamental concepts in the medical device industry.

Learning Level: Basic

Total Length of Course: 1 Hours

RAC Points: 1

Medical Device Certificate Core Course

Enrollment Period: 12 months

Learning Objectives

Provide the definition of “medical device”

Describe how medical devices are classified

Outline the activities within a medical device lifecycle phases, and

Discuss different types of medical device marketing authorizations

Lesson Titles

Lesson 1: Medical Device Definition and History