Our products meet the highest international regulatory standards, enabling market access across major global healthcare markets.
ISO 13485:2016 Medical Devices — Quality Management Systems
Our quality management system is certified to ISO 13485:2016, ensuring that every product meets the stringent requirements for medical device manufacturing, from raw material procurement to final inspection and distribution.
European Conformity — Medical Device Regulation (MDR 2017/745)
Our product range carries CE marking under the EU Medical Device Regulation, enabling market access across all EU member states and EEA countries. Our CE Technical File is maintained and regularly audited.
U.S. FDA 510(k) Clearance & Establishment Registration
We are a registered medical device establishment with the U.S. FDA, and our products have received 510(k) clearance for marketing in the United States. Our facility is subject to FDA inspection.
ISO 9001:2015 Quality Management Systems
In addition to our medical device-specific QMS, our organization maintains ISO 9001 certification, demonstrating our commitment to continuous improvement and customer satisfaction across all business processes.
Medical Device Single Audit Program
Through MDSAP certification, our quality management system has been assessed against the regulatory requirements of five major medical device markets, streamlining audits and ensuring multi-market compliance.
At MedFabx, regulatory compliance is not just a requirement — it is the foundation of our quality culture. We maintain active certifications across all major medical device regulatory frameworks, ensuring that our products can reach healthcare professionals and patients wherever they are needed.
Our regulatory affairs team continuously monitors evolving global regulations to ensure ongoing compliance. We welcome audits from notified bodies, regulatory authorities, and customer quality teams at our manufacturing facility.
If you require copies of our certificates or technical documentation for your regulatory submissions, please do not hesitate to contact us.
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