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 certified

Comply with NMPA regulatory requirements

Passed a variety of authorities on-site audits from different countries

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

Product Certificates

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

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