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Certification & quality
Our commitment to quality is backed by the standards and certifications the medical-device industry demands.
Certificates & accreditations
Our Sonepat manufacturing facility is certified to internationally recognised medical-device quality standards. Click a certificate to view or download it.
ICMED 13485 : 2020
Indian Certification for Medical Devices (ICMED) quality management system, issued by MTIC InterCert (NABCB accredited) for our Sonepat facility — covering the design, manufacture and supply of custom perfusion systems, arterial line blood filters and related devices.
ISO 13485 : 2016
Medical Device Quality Management System certified by BSCIC to ISO 13485:2016 — covering the design, manufacture and supply of custom perfusion systems, cardiopulmonary bypass arterial line blood filters, connectors and accessories.