Medical Device Regulations

This course will provide a detailed overview of medical device development from a realistic industrial perspective using recorded lectures and slides which are all provided. The processes used in corporations to conceive and develop devices will be explored from a research, regulatory, clinical, QA/QC, marketing, engineering, and legal perspective under the umbrella of project management techniques. Material will be presented as an aide to students who wish to decide on careers in either industry or academia.

For students or newly minted engineers that find themselves participating on project teams, this course will give them basic knowledge needed to function.

For Professors interested in making a change or learning more about their commercial counterparts, this course will bridge the knowledge gap and convey an understanding of what accommodations can be made to do that.

Anyone that needs an overview of the major roles found in device companies can benefit from this course.

Course Goals

• Understand the various disciplines involved with medical device development
• Know the roles that different departments and professions play in medical device development
• Describe the regulatory structure for medical devices in the USA
• Use this information in choosing a medical device profession
• Function as a member of a medical device project team