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
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CE

1) Comply with IVDD 98/79/EC
2) Comply with MDD 93/42/EEC
3) EN ISO 13485:2016 certif_ied
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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.
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Product Certificates

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