Fortress Diagnostics Achieves ISO 13485 Certification

30 June, 2021

We are proud to announce that Fortress Diagnostics Ltd has once again achieved EN ISO 13485:2016 Certification in a recent audit by the Polish Centre for Testing and Certification (PCBC).

The PCBC states that Fortress Diagnostics is in conformance with EN ISO 13485:2016 in the following scope of activities; the design, development, manufacturing and distribution of In Vitro medical reagents and instrumentation for clinical chemistry, immunoassay (ELISA’s), latex, serology, microbiology, rapid test, pregnancy, blood grouping, immunology, coagulation, haematology and electrolytes.

The PCBC is a testing and certification company with 60 years’ experience in the certification of management systems, testing and certification of products and training. The ISO 13485 Certification is an internationally recognised standard in relation to quality management systems for medical products. The standard includes requirements referring to management systems and is intended for organisations willing to evidence the ability to provide medical products and related services. 

The aim of EN ISO 13485:2016 is to facilitate the harmonizing the regulatory requirements for medical products with quality management systems.

For Fortress Diagnostics, achieving EN ISO 13485:2016 in the outlined scope of activities reflects our dedication to advancing global healthcare by delivering high standards of quality and ensures customers can have confidence in our products and the quality of our services with the knowledge that we are dedicated to maintaining high standards.  

For more information on the Polish Centre for Testing and Certification visit,

For more information on the Fortress Diagnostics product range visit or contact


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