Comprehensive Cardiac Care, pllc

Specializing in:

• FDA Panel Preparation
• Medical Device Design Testing
• Clinical Trial Design
• Pre-Clinical Trial Design
• Clinical Trial Implementation
• FDA Submission Consulting
• Regulatory Strategy Planning
• Post-Market Trial Design
• Business Development
• Provide Consulting to Investors on Medical Device Sectors
  

Helen S. Barold, MD, MPH, FACC, FHRS has over 10 years of experience in Cardiology and Cardiac Electrophysiology. She has over 8 years of experience in regulatory evaluation of medical devices. Shw was a medical office in the Office of Device Evaluation at the FDA. She was the Chief Medical Office for a medical device company that was aquired by a larger company. 

Dr. Barold has extensive experience in the medical device arena including pre-clinical testing and device design and implementation, FDA submissions and FDA panel presentation.