ICsense 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
Examples
- 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)
