ExpertiseUpdated on 6 October 2025
Performance Evaluation Plan for IVD
Performance evaluation ingeneer 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
Attached files
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Expertise
Performance Evaluation Plan for IVD
- MEDICINE
- BIOLOGY / BIOTECHNOLOGY
- INDUSTRIAL BIOTECHNOLOGY
Vincent GENTY
CEO at Amarok Biotechnologies
Pleslin Trigavou, France
Service
Analytical and clinical performance evaluation of in vitro diagnostic medical devices (IVD-MDs)
- MEDICINE
- Consulting
- Testing & Analysis
- BIOLOGY / BIOTECHNOLOGY
- INDUSTRIAL BIOTECHNOLOGY
Vincent GENTY
CEO at Amarok Biotechnologies
Pleslin Trigavou, France
Service
Analytical and clinical performance evaluation of in vitro diagnostic medical devices (IVD-MDs)
- MEDICINE
- Consulting
- Testing & Analysis
- BIOLOGY / BIOTECHNOLOGY
- INDUSTRIAL BIOTECHNOLOGY
Ludovic CHAILLET
Performance evaluation ingeneer at Amarok Biotechnologies
Pleslin Trigavou, France