Our Certifications
Quality and compliance are at the core of everything we do
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ISO 13485
ISO 13485:2016 β Medical devices quality management system
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CE MDR
CE MDR (EU 2017/745) β European market compliance
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FDA
FDA 510(k) β US market clearance
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CFS
Certificate of Free Sale β For international registration
We work exclusively with factories that maintain active ISO13485 certification and applicable product registrations. Contact us for specific certificate copies.