Medical Device Regulations

TASA ID:

On Tuesday, July 15, 2014 at 2:00 p.m. (ET), The TASA Group in conjunction with medical device expert Christina Bernstein presented a free, one-hour, interactive webinar, Medical Device Regulations, for all legal professionals.

Ms. Bernstein discussed FDA medical device regulations.  She covered the code of Federal Regulations, as well as the classes of medical devices and special cases for IDE and pediatrics.  Ms. Bernstein also provided information on FDA product code databases, FDA inspection findings, as well as MAUDE/MDR databases. In addition, she discussed internal manufacturer data, standards and auditors.

About the Presenter:

Christina Bernstein has a Master’s Degree in Medical Device and Diagnostic Engineering from the University of Southern California. She manufactures an FDA cleared Class 2 medical device accessory in the United States and is a regulatory consultant to USA manufacturers of cancer care devices. Ms. Bernstein has worked for a large, publicly traded Class 3 medical device manufacturer and has more than 10 years of work experience in medical and non-medical industries.