Quality and Accreditations

Quality and Accreditations

Fortress Diagnostics is committed to developing and manufacturing the highest quality products which not only meet, but exceed, market requirements and customer performance expectations.

This high-quality standard is achieved by a systematic and disciplined approach from employees in all activities associated with the manufacture and delivery of our products.

We operate a Quality Management System certified to ISO 13485:2016 for the design, development, manufacturing and distribution of in Vitro Diagnostics medical reagents and instrumentation for clinical chemistry, immunoassays (ELISA’s), latex, serology, microbiology, rapid test, pregnancy, blood grouping, immunology, coagulation, haematology and electrolytes.

We strive to continually improve the effectiveness of our Quality Management System through an ongoing review of specific and measurable quality objectives, including QC testing, internal reviews and customer feedback.

ISO 13485

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