Quality Commitment

COMMITTMENT TO QUALITY

At Noraxon we pride ourselves in consistently delivering the highest quality research-grade products to our customers. We achieve this level of excellence through a commitment to our customers, our products and our quality management system. In accordance, we follow the strictest adherence to all applicable regulatory policies and certifications including:

ISO 13485:2012, Medical Devices (Quality Management Systems). Requirements for Regulatory Purposes (Registrar – Intertek: Registration # MED-0037b)

 

FDA 510k, Registered with the US Food and Drug Administration (FDA Registration: # 2098416 )

 

CE Approval, Product Certification to European Union MDD – (AMTAC Certification # 943 CE)

 

Canadian Medical Device Regulation (CMDR), SOR98/282 – License # 79259

 

Registered Australian Therapeutic Goods – Certificate # DV-2011-MC-00058-3

 

Japanese JPAL MHLW Ordinance #169 Compliant – MAH, Sakai Medical

 

Brazil Inmetro Ordinance 350/2010 Compliant

 

cGMP Compliant (Good Manufacturing Practices)

 

Consensus Medical Electrical Equipment Standards Compliant (60601-1 for Safety, 0601-1-2 for Electro-Magnetic-Compatibility and 60601-2-40 for EMG)

 

Chinese CFDA Registration – Pending under Qualtech