Year in review - 2018 Software Regulatory

Year in review - 2018 Software Regulatory

Below is the slide presentation I gave to the Orange County Regulatory Affairs (OCRA) Year in Review.

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Frances Cohen

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.

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Promenade Software, Inc. specializes in software development for medical devices and other safety-critical applications.
Promenade is ISO 13485 and CyberMed • Cloud is SOC2 Type II certified.

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