AnSem, a Cyient company, has received ISO 13485:2016 certification for design, supply of integrated circuits to MedTech market
The new certification is in addition to the ISO 13485 certifications the company has had for engineering since 2009 and manufacturing since 2007 and is a testament to its expertise in developing advanced ICs for the MedTech market.
Cyient announced that AnSem, a Cyient company, has received the ISO 13485:2016 certification for design and supply of integrated circuits to the MedTech market.
This certification also applies to the supply of custom ASIC components. Cyient provides a one-stop-solution to its MedTech OEM customers with a smooth path from prototype approval to high-volume production and continuous support during the lifetime of the medical product.
Speaking on the achievement, Suman Narayan, Sr Vice President and Head of the MedTech & Healthcare and Semiconductor business units, Cyient said, “We are excited to receive the ISO 13485 certification. Cyient has 20 years of OEM and electronic box-build experience in medical devices, and this certification expands our product development and digital solutions offering for the development and supply of custom ASIC for our MedTech customers.”
Stefan Gogaert, General Manager, AnSem, commented, “The ISO 13485 certification demonstrates our commitment to providing high-quality ASIC design and supply to our medical customers, enabling them to meet regulatory requirements and device certification and CE marking / FDA approval.”