ICsense was awarded the ISO 13485 certification for medical devices in 2012 as an extension to its ISO 9001:2008 certified quality management system. ICsense has been working in medical for over 10 years with a quality management system that is compliant with automotive, space and safety critical applications. ICsense decided to take its medical capabilities to the next level with the extension to ISO 13485. This severe deepening of the continual improvement effort in the QMS allows ICsense to design, develop and supply medical ICs for all medical devices up to Class I.
ICsense develops ASICs for a multitude of medical applications such as cochlear implants, hearing aid sound processors, implanted battery chargers, medical patches, medical imaging, ECG readout systems and MEMS lab-on-chips for cancer cell detection. The latest development is a first of a kind, innovative deep brain stimulation ASIC. ICsense is supporting this customer from idea to production, qualification and supply.
Watch the video testimonial of Cochlear here.
Examples of medical projects
||An Implantable Pulse Generator (IPG) neuro-stimulating system with 24 amplitude independent channels (read more)|
||A complete brain stimulation ASIC, including power management, high-voltage generation, stimulation and recording (read more)|
||The electronics are implanted and wirelessly powered, therefore a low current consumption is crucial (read more)|
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Read more on medical projects at ICsense