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ExpertiseUpdated on 30 September 2025

Performance Evaluation Plan for IVD

CEO at Amarok Biotechnologies

Pleslin Trigavou, France

About

Performance evaluation is a continuous improvement process.

Support for post-market surveillance of IVD-MDs, ensuring continuous compliance and effectiveness.

Our area of expertise is an expert guidance on analytical parameters and regulatory requirements related to IVDR, facilitating the preparation of tailored regulatory documents.

Scientific Validity

Association of an analyte with a clinical or a physiological state. Systematic review of the existing (peer-reviewed) literature relevant to the analyte.

If gaps are identified, additional data are needed by performing proof of concept, preclinical performance studies.

Analytical Performance

Ability to correctly detect or measure a particular analyte (specificity, sensitivity, reproducibility, stability, etc.).

Clinical Performance

Ability of the device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user.

Field

  • BIOLOGY / BIOTECHNOLOGY
  • INDUSTRIAL BIOTECHNOLOGY
  • MEDICINE

Organisation

Amarok Biotechnologies

Other

Pleslin-Trigavou, France

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