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
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)
(Wednesday) 11:00 am - 1:00 pm CST
TMAC Event Center: 1600 E. Pioneer Parkway, Suite 430, Arlington, TX 76010
TMAC Business Advisors