Medical Device Development
A basic level primer for those starting their careers developing medical devices in a heavily regulated environment.
Description
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.
What You Will Learn!
- Function as a member of a medical device project team
- 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
Who Should Attend!
- Biomedical Engineering (or other STEM majors) that want to know what medical device development in industry is like
- Academics that need to understand the difference between Industry and Academia
- Physicians that have a medical device idea and wish to know the basics of how to get started
- People fresh out of college that need a basic primer on device development for their job
- Graduate and Undergraduate students whose schools do not offer courses like this one
- Medical Device Engineers with 0 to 2 years of experience that need a basic education about the various roles in device development
- This course is NOT for seasoned medical device project professionals