Quality & Certifications
Quality and compliance at every stage
We operate a medical-device quality management system focused on process control, risk management, traceability and continuous monitoring across the scope of our certified activities.
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
Assr Medical Technology holds a certificate confirming that its quality management system conforms to the requirements of ISO 13485:2016 within the scope defined in the certificate.
Certificate numberCB-MS-3912
Certification bodyARS Certification
AccreditationUAF — United Accreditation Foundation
VerificationIAF CertSearch
Regulatory expertise and risk management
Our team’s regulatory expertise supports compliant market access and medical-device risk management in line with ISO 14971, alongside post-market surveillance activities.
Quality management across the product lifecycle
SourcingManufacturingDistributionImplementationSupport
Let’s Advance Healthcare Together
Connect with our team to explore diagnostic, surgical, and medical technology opportunities.