Below is the slide presentation I gave to the Orange County Regulatory Affairs (OCRA) Year in Review.
Frances Cohen is President of Promenade Software Inc., a leading software services firm specializing in medical device and safety-critical system software. Frances has
more than 20 years of experience leading software teams for medical
device software. Starting with heart defibrillators for Cardiac Science and following with Source Scientific LLC and BIT
Analytical Instruments Inc., Frances has overseen dozens of projects
through development and the FDA, including IDEs, 510(k)s, and PMAs. Frances has a B.S. in computer engineering from the Technion, Israel Institute of Technology.
About Promenade Software
Promenade Software, Inc. specializes in software development for medical devices and other safety-critical applications. Promenade is ISO 13485 and 9001 certified.