This class is geared to provide you an overall understanding of Medical device classifications and regulations for small manufacturers or medical device entrepreneurs.

• FDA’s role in regulating medical devices
• What is a medical device and medical device classification?
• Medical Device Current Good Manufacturing Practices (cGMPs). Component Manufacturers?
• Defining your intended use is key!

Upon completion of this training, students will be able to:

• Understand the basic FDA regulations and requirements for a medical device

• Understand basic requirements of good manufacturing practice (cGMP) for a medical device 

Who Should Attend:

Biomedical Scientists, Entrepreneurs, Startups, Designers, and Medical Device/Component Manufacturers

(This event is being offered in a hybrid format: online and in-person)