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The higher the risk class, 
the more robust the evidence must be

IVD performance evaluation: A guide to tailoring your strategy to the risk class (A, B, C, D)

You’re developing an in vitro diagnostic (IVD) device and wondering about the differences between IVDR classes A, B, C, and D and how they affect your performance evaluation?
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Wine production: flow cytometry validated by the OIV

Flow cytometry is officially recognised as a benchmark method for monitoring yeast viability in musts and wines. Resolution OIV-OENO 713A-2025, formalised by the International Organisation of Vine and Wine (OIV), marks a major step forward for the wine industry.
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Expertise, impartiality and ISO17025: Amarok Biotechnologies’ LEP at the service of medical devices

Ludovic Chaillet, engineer at LEP, and Alexandre Rivoallan, reference technician, share their expertise on the evaluation process and explain why manufacturers call on Amarok Biotechnologies to validate their products.
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News, Regulation

The administrative challenges of IVDR Regulation 2017/746

Explore the administrative constraints related to this new regulation and the organizational implications for the in vitro diagnostic medical device (IVD) industry.
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Amarok Biotechnologies, a French performance evaluation laboratory, renews its ISO 17025:2017 accreditation with an extension to blood group immunohematology

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Bretta test B Amarok biotechnologies

Launch of the revolutionary Bretta test B method for immunomagnetic purification of Brettanomyces coupled with flow cytometric analysis

Discover the future of oenology with Bretta Test B: a revolutionary advance in the detection and purification of Brettanomyces in wine.
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