A startup medical device company needed to test its vascular monitor which was designed to measure temperature in arteries to determine if there was inflammation. Voler was selected to develop the software and electronics.
The company needed to monitor temperature changes as small as 0.05 degrees C using an unshielded thermocouple probe. The equipment was used in studies on animals and humans. The electronics met FDA requirements, including isolation from the power line for use on humans. Emissions and immunity testing was supervised by Voler. We wrote a “Failure Modes and Effects Analysis” (FMEA) for FDA compliance.