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.
VALUE CHAIN
Auditing & Analyzing
MEDICINE
Clinical Research, TrialsDiagnostics, Diagnosis
THERAPEUTIC AREA
Diagnostics