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ServiceUpdated on 30 September 2025

Analytical and clinical performance evaluation of in vitro diagnostic medical devices (IVD-MDs)

CEO at Amarok Biotechnologies

Pleslin Trigavou, France

About

Amarok Biotechnologies' Performance Evaluation Laboratory is dedicated to the IVD-MD industry.

Over the last 15 years, it has conducted analytical and clinical performance evaluations, verifications and validations as independent third-party (According to ISO 17025 and ISO17029 description). All these studies have been conducted under IMDRF, CLSI or MDCG adapted protocols for IVDD and IVDR certification. Over 200 different evaluations have been realized including preliminary evaluation, precision, linearity, interference testing, verification of precision and estimation of bias, clinical studies.

It has access to various kind of biological specimens according to the European and French ethics laws through a large network of clinical laboratories.

We are the only French Lab accredited under ISO 17025 for MD IVD evaluation.

Type

  • Consulting
  • Testing & Analysis

Applies to

  • BIOLOGY / BIOTECHNOLOGY
  • INDUSTRIAL BIOTECHNOLOGY
  • MEDICINE

Organisation

Amarok Biotechnologies

Other

Pleslin-Trigavou, France

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