Biopass Medical Systems has extensive experience in medical device hardware design meeting all U.S. and International standards.  This ensures your product will meet all regulatory safety requirements worldwide.


Our capabilities include:

  • IEC 60601-1 (ed 3.1)  & 14971 Annex ZA compliant designs
  • Analog and Digital circuit design
  • Type BF Patient connected and defibrillator-proof circuits
  • Ultrasound probes, beamformers and displays
  • Type BF Patient connected and defibrillator-proof circuits
  • ESD and EMC compliant designs
  • Motorola, Intel, AMD, Freescale and Microchip Microprocessors
  • Intel and AMD single board computers
  • Medical-Grade linear and switching power supplies
  • Wireless (including WiFi, 4G and Bluetooth) Networking
  • Programmable Logic (FPGA, CPDL and DSP) designs
  • Printed Circuit Board Design and Layout
  • Custom graphics displays and membrane switches
  • Touch Screen, LED, LCD, TFTN and EL displays
  • Temperature, humidity, oxygen and SPO2 sensors
  • Strain gages, pressure transducers, airflow & position sensors
  • Blower and pump controllers, DC brushless motor controllers
  • Temperature, humidity and oxygen regulation controls
  • Redundant and diverse circuitry to ensure safety and reliability
  • Cable Assembly design
  • Test Fixture design and assembly