We Are The Movement. Data. People.
Committed to Excellence
These customers and partners trust Noraxon to enable
a more complete understanding of human movement.
In today’s complex human movement environment, you need a simple solution for getting the complete, evidence-based biomechanics data you need.
- Manufacturing R&D
- Occupational Therapy
- Performing Arts Medicine
- Physical Therapy
- Product Development
Our Commitment to Quality
At Noraxon, accurate data is our passion. We pride ourselves on consistently delivering the highest-quality research-grade products. We achieve this level of excellence through a quality-management system that demonstrates the strictest adherence to all applicable regulatory policies and certifications.
ISO 13485:2016, X ISO 13485:2016 Medical Devices (Quality Management Systems). Requirements for Regulatory Purposes (Registrar – Intertek: Certificate #0071071-01) FDA 510k, X FDA 510k Registered with the US Food and Drug Administration (FDA Registration: # 2098416 ) CE Approval, X CE Approval Product (#810, 610, 616, 546, 548) Certification to European Union MDD – (BSI Certification # CE 679720) Registered Australian Therapeutic Goods, X Registered Australian Therapeutic Goods Certificate # DV-2011-MC-00058-3 Japanese JPAL MHLW, X Japanese JPAL MHLW Ordinance #169 Compliant – MAH, Sakai Medical Brazil Inmetro, X Brazil Inmetro Ordinance 350/2010 Compliant cGMP Compliant, X cGMP Compliant Good Manufacturing Practices Chinese CFDA Registration, X Chinese CFDA Registration Pending under Qualtech Consensus Medical Electrical Equipment Standards Compliant. X Consensus Medical Electrical Equipment Standards Compliant 60601-1 for Safety, 0601-1-2 for Electro-Magnetic-Compatibility and 60601-2-40 for EMG