Quality System

US FDA

1) Passed US FDA inspections in the past 3 consecutive times (2008 & 2016 with “Zero Defect”)

2) Comply with CGMP/QSR requirements

CE

1) Comply with IVDD 98/79/EC

2) Comply with MDD 93/42/EEC

3) EN ISO 13485:2016 certif_ied

Comply with NMPA regulatory requirements
Passed a variety of authorities on-site audits from dif_ferent countries

Germany TÜV SÜD, Brazil ANVISA, Korea FDA, Ukraine MOH, France LNE, Nigeria FDA, GCC SGH, Iran MOH, etc.

Product Certif_icates

US FDA cleared CE cleared CFDA/FSC certif_ied ISO15197 certif_ied MDSS certif_ied

White Papers

On Call Sure Blood Glucose Monitoring System IDK (Germany) Evaluation Report On Call Sharp Blood Glucose Monitoring System IDT (Germany) Evaluation Report On Call Plus Blood Glucose Monitoring System NHS (UK) Evaluation Report