Abel and Wolf Consulting has been founded to provide an entity dedicated to guiding medical device development and evaluation, and to support communication with FDA. Specializing in non-active cardiovascular devices, our services include:

• Engineering support

• Device evaluation
  strategy development

• Clinical evaluation strategic planning

• FDA submission planning

• Drafting or review of FDA submissions

• FDA meeting support

Through application of our combined experience, our goal is to facilitate the access of beneficial medical devices to patients.