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IC’Alps granted ISO 13485 : 2016 certification for design and supply of Integrated Circuits for medical devices

Meylan, FRANCE – December 05, 2019 - IC’Alps, French expert in design and supply of custom integrated circuits, announced today that it has been granted the prized ISO 13485:2016 certification for its Quality Management System (QMS).


ISO 13485:2016 is an international quality standard required by the medical device industry, to ensure the safety of sensitive devices such as pacemakers. To be certified, IC’Alps demonstrated its commitment to the highest level of quality controls, and its ability to design, develop and supply medical Application Specific Integrated Circuits (ASIC) that consistently meet customer and regulatory expectations.


“I am proud of IC’Alps’ team’s commitment to high quality standards, thus allowing this milestone to be reached within just 18 months from its creation”, commented Etienne Flesch, CEO of DOLIAM Group, which includes Vermon, the world leader in composite piezoelectric transducers. DOLIAM is also IC’Alps’ majority shareholder. “This ISO certification represents a major differentiator and added value for the company and reflects its commitment to provide highly reliable ASIC for medical devices up to class III” adds Jean-Luc Triouleyre, CEO of IC’Alps.


IC’Alps has an extended design expertise to develop mixed-signal ASIC for implantable or wearable medical devices, with a focus on power optimization and miniaturization in one chip, multi-sensor signal acquisition, wireless communication interfaces, and security features. With this certification, the company now also has the ability to ensure the continuous improvement of internal operational processes, the long-term reliability of its supply chain, and the traceability of design projects, contributing to accelerate medical ASIC development in view of customers’ device certification and CE marking process/FDA approval.


According to Etienne Flesch: “This recent ISO 13485:2016 completion paves the way to promising perspectives for IC’Alps in medical ASIC, considering its involvement in an on-going European project for a digital stethoscope implant, as well as ground-breaking medical ASIC circuits being developed or under discussions”.


IC’Alps is looking forward to supporting the medical community with on-demand ASIC. To discuss a potential project, please contact Rémy Girin our business manager


For more information about IC’Alps’ expertise, please visit our website

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