AnSem Receives ISO 13485:2016 Quality Certification

AnSem · AnSem Receives ISO 13485:2016 Quality Certification

The certification is a testament to the company’s expertise in developing advanced IC design and supply for the MedTech market.

Hyderabad, India, February 21, 2020: Cyient, a global engineering and technology solutions company, today announced that AnSem, a Cyient company received the ISO 13485:2016 certification for design and supply of integrated circuits. ISO 13485:2016 is an international standard for Quality Management System essential for the medical device industry to ensure the safety and traceability of MedTech products.

The recognition reaffirms that AnSem has a 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 system.

AnSem is Cyient’s center of excellence for custom turnkey signal ASICs: it is managing the complete life cycle—from design requirements to high-volume production until end-of-life. 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.

As a specialist in analog mixed-signal custom ASIC solutions, AnSem has deep expertise in wireless energy transfer, sensor signal acquisition, wireless communication, high-speed interconnect, and embedded power management.

Speaking on the achievement, 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, a Cyient Company, 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.”