Medical Device Risk Analysis

TASA ID: 4338

On May 28, 2015, The TASA Group, in conjunction with medical device expert Christina Bernstein, presented a free, one-hour interactive webinar presentation, Medical Device Risk Analysis. During this presentation, Ms. Bernstein discussed:

• Why you need to know about risk and medical devices
• Clinical data and devices
• Adverse events handling
• Identifying hazards
• Assigning risk values – simple to very complex
• How manufacturers manage risk

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.