Amarok Biotechnologies is delighted to announce the renewal of its ISO 17025:2017 accreditation for its Performance Evaluation Laboratory (LEP), with an extension to blood group immunohematology, a key area in in vitro diagnostics (IVD).
Amarok Biotechnologies is accredited EN ISO/IEC 17025:2017 for the evaluation of the analytical performance of in vitro diagnostic medical devices (IVD MD) by the Human Health division of COFRAC. This recognition testifies to its ongoing commitment to excellence and quality in its testing and analysis processes.
The extension of its accreditation to blood group immunohematology means that its expertise is recognized for the research and determination of erythrocyte antigens (for ABO, antibodies) and for blood group determination (Couple reagents and immunohematology automats and immunohematology reagents).
It increases its capacity to meet the needs of its IVD device manufacturer customers.
Going through an ISO 17025:2017 accredited laboratory, particularly in the field of hematology, is crucial for many players, as this accreditation guarantees the reliability and accuracy of analyses.
ISO 17025:2017 standards ensure that the laboratory uses validated test methods and has the necessary technical skills, which is essential for high-quality diagnostic results. This is particularly important in the medical field, where critical treatment decisions are based on these results.
Amarok Biotechnologies would like to express its gratitude to the Brittany Region for its invaluable support, which was decisive in helping us to obtain this accreditation. Its support strengthens our ability to innovate and offer high-quality diagnostic solutions.
Go to the COFRAC accreditation certificate
About Amarok Biotechnologies
Amarok Biotechnologies is an analysis, testing and research laboratory specializing in biotechnologies applied to in vitro diagnostics. Located in Saint-Malo, it is a forerunner in the evaluation of medical devices, food and environmental safety, offering personalized support to its customers.
Press contact
Benoit Martin
benoit@digiobs.com
06 66 02 77 10