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Home > Regulatory & Compliance
Regulatory & Compliance
Trusted Partner for Regulatory, Compliance Dialysis Infrastructure & Products
Aurum Medion adheres to international medical device quality standards & best
practices for CE certification, TMDA registration, ISO 13485 compliant manufacturing & export documentation support across Africa & the Middle East
ISO 13485 Certified
CE Mark Certified
Export Ready Logistics
Regulatory - Compliant. Operationally Proven. Export - Ready
Regulatory - Ready, Export - Aligned, & Compliant Supplies
Ensuring ISO 13485:2016 certified manufacturing, CE conformity and aligned export documentation for
International Dialysis market compliance
Quality Assurance Framework
Import Registration Guidance
ISO 9001 : 2015
Aurum Medion is ISO 9001:2015 accredited in the disposable Medical Devices quality standard. ISO 9001 specifies the standards for our organization’s Quality Management System to Design, Manufacture, and Deliver medical devices that satisfy customer, statutory, and regulatory requirements. The standard also lays out a structure for evaluating customer perception and making changes.
ISO 13485 : 2016
Aurum Medion Technology is ISO 13485:2016 certified for disposable medical devices. We use competent and efficient quality management methods to assure consistent quality, product safety, and the long-term success of our products. As a result, you can assured that our product will fulfil all applicable regulatory standards across the world.
EU 2017 / 745 MDR
Aurum Medion is approved for disposable medical devices. The CE mark signifies that our product complies with EU health, safety, and environmental protection requirements. It means that the product may be sold freely in any region of the European Economic Area, regardless of where it was manufactured.
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