From Zero to ISO: Full Laboratory Launch Cycle

Medical Laboratory

Diagnostics

Laboratory environment design

Planning of premises, technological workflows, and biosafety zones in compliance with international requirements

Alignment with ISO 15189 (quality and competence of medical laboratories) and ISO 17025 (general requirements for the competence of testing laboratories)

Zoning of spaces according to air cleanliness classes, biological safety, and optimization of sample logistics

Supply and installation of analytical equipment

A full cycle of supply, installation, and commissioning of modern analytical systems for laboratory diagnostics, including:

Clinical hematology

Clinical chemistry and biochemistry

Immunological and serological testing

PCR

Microbiology and bacteriology

Validation and certification

Internal and external validation of laboratory processes in compliance with ISO 15189 and ISO 17025

Ensuring analytical accuracy, reproducibility, and participation in external quality assessment (EQA) programs in accordance with ISO/IEC 17043

Розробка стандартних операційних процедур (SOP), методик, протоколів

European diagnostic quality — in every result

All installed equipment complies with the EU In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) and bears the CE marking, guaranteeing its safety, effectiveness, and suitability for clinical use.

Installation processes are carried out in line with manufacturer technical specifications, biosafety requirements, and integration with the Laboratory Information System (LIS).