Cyient, a global engineering and technology solutions company has announced that AnSem, a Cyient company, has received the ISO 13485:2016 certification for design and supply of integrated circuits to the MedTech market.
AnSem is Cyient’s center of excellence for custom turnkey mixed-signal ASICs and is managing its complete life cycle—from design requirements to high-volume production until end-of-life.
“The recognition reaffirms the company’s long-standing track record in developing advanced ASIC circuit design for class III implants, medical patches, hearing aids, medical imaging, and nurse call localization and alarm systems. From design requirements to high-volume production until end-of-life, Cyient provides custom turnkey mixed-signal ASICs and manages its complete life cycle,” according to the press release.
“This certification also applies to the supply of custom ASIC components. Cyient provides a onestop-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,” it added.
Suman Narayan, Sr. Vice President and Head of the MedTech & Healthcare and Semiconductor business units, 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.”
ISO 13485:2016 is an international quality management standard essential for the medical device industry to ensure the safety and traceability of medical products.
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