Medical devices go through a long and complex process of development before being made available for therapeutic or diagnostic use. This process involves professionals from varied backgrounds, such as scientists, clinicians, regulatory specialists, legal experts and business specialists.
Whether you are considering a career in medical device development or simply seeking a better understanding of the medical device business, this course acts as a primer—a basic introduction to medical devices and general aspects of product and regulatory lifecycles. It also provides a brief history of medical device regulation and information on basic regulatory principles and concepts as they apply to medical devices. This course lays the foundation for a more in-depth study of medical devices and how they are regulated in the US and EU.
Learning Objectives
Upon completion of this course, participants will be able to:
- Provide the definition of “medical device”
- Describe how medical devices are classified
- Outline the activities within a medical device’s lifecycle phases
- Discuss different types of medical device marketing authorizations
Target Audience
This course is beneficial for new regulatory and clinical professionals, as well as business and investment professionals looking to learn more about fundamental concepts in the medical device industry.