Medical quality ISO13485

Medical quality ISO13485

Medical quality: ISO 13485:2012

ICsense was awarded the ISO 13485:2012 certification for medical devices as an extension to its ISO 9001:2008 certified quality management system. ICsense has been working in medical for 10 years with a quality management system that is compliant with automotive, space and safety critical applications. ICsense now 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.