Quality & Regulatory

Quality Sytem for partners

Regulatory support and/or approvals

We Are With You All the Way...

Quality System for MFG Partners

ISO 9001:2015, ISO 13485:2016 Compliance

EU MDR, IVDR Compliance

FDA Listed

CFDA certifed MFG

Nintei Certification Medical Device

Product Compliance Testing (IEC, UL...)

Clinical Trials(Local Hospitals)

Product Registration (HK, China, KFDA, Japan...)

Product IP/ Patent Apply, Maintenance