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Amarok Biotechnologies

About

The Performance Evaluation Laboratory of Amarok Biotechnologies specializes in the assessment of in vitro diagnostic medical devices (IVDs). It is accredited to the EN ISO/IEC 17025:2017 standard, ensuring the reliability and quality of its analyses.

The laboratory supports manufacturers throughout the entire lifecycle of their products by providing analytical and clinical performance evaluations in compliance with the European IVDR (EU 2017/746). It also offers tailored support for the preparation of technical documentation related to performance evaluation.

The laboratory’s services are designed to guarantee complete confidentiality, uphold ethical standards, and maintain rigorous quality management in line with international standards.

LIFE SCIENCE

Diagnostics

VALUE CHAIN

Auditing & Analyzing

MEDICINE

Clinical Research, TrialsDiagnostics, Diagnosis

THERAPEUTIC AREA

Diagnostics

Representatives

Ingénieure Laboratoire d'évaluation de performances (DM-DIV)

Amarok Biotechnologies

CEO

Amarok Biotechnologies

Performance evaluation ingeneer

Amarok Biotechnologies

Marketplace (3)

  • Expertise

    Performance Evaluation Plan for IVD

    Regulatory expertise, personalized consulting and support

    • MEDICINE
    • BIOLOGY / BIOTECHNOLOGY
    • INDUSTRIAL BIOTECHNOLOGY
    Author

    CEO at Amarok Biotechnologies

    Pleslin Trigavou, France

  • Service

    Clinical sample access

    Clinical samples recruitment.

    • Other
    • MEDICINE
    • Consulting
    • LIFE SCIENCE
    • Certification
    • Testing & Analysis
    • Research & Development
    • BIOLOGY / BIOTECHNOLOGY
    • INDUSTRIAL BIOTECHNOLOGY
    Author

    CEO at Amarok Biotechnologies

    Pleslin Trigavou, France