ISO13485 ICsenseICsense is ISO13485 certified for medical ASIC (Application Specific IC) developments. For over 15 years, the mixed-signal ASICs of ICsense are used in implantable class III medical devices, ultra-low-power devices with enhanced battery life, hearing aid devices and wearables/portables for renowned medical device manufacturers.

Through its systematic and certified development process, ICsense can ensure the quality, safety and long-term reliability for medical ASICs.

Our approach in medical ASIC developments

  • ISO 13485:2016 certified for design, development and production
  • Ultra-low-power in combination with high-voltage for long battery life
  • Minimization of external components for minimal device size
  • MRI  / EMC / ESD compatibility
  • Hazard and risk management: HARA, FMEA, …
  • Support of FDA and CE marking process


  • X-ray imaging chipset
  • Ultrasonic TX/RX
  • Power management chip
  • Deep brain stimulator
  • Li-ion Battery charger
  • Nerve stimulation IC
  • Hearing aid power mgmt
  • Lab-on-chip interface
  • ECG readout
  • Wireless power/data transfer (read more)

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