THE QUALITY OF THE PRODUCTS AND SERVICES WE PROVIDE DEFINES OUR COURSE AND VALUES.
The development and production of IVD medical devices in INEP is the result of continuous scientific research work in the fields of immunology, immunochemistry, endocrinology and glycobiology. Our mission is to develop, produce and offer a complete panel of high quality immunoassays for quantitative determination of biologically active substances for thyroid function, fertility and reproduction, diabetes, tumor markers, molecular immunology (determination of human immunoglobulin concentration, autoantibodies, diagnosis of infectious diseases). We are dedicated to providing high quality tests and supporting our customers.
INEP takes necessary measures to ensure that the production process follows the principles of quality assurance appropriate for the IVD products. It means that INEP establish the organisational structure and defined responsibilities, validated manufacturing processes and systematic quality control of production and the means to monitor the performance of the quality system. INEP’s highly educated and well-trained personel is responsible for iodination, kit standardization and validation/verification.
In order to understand the latest developments and needs of different scientific, medical or environmental fields, as part of our R&D activities, we offer collaborations to conduct a purposeful product development.
INEP manufactures in vitro diagnostic medical devices (IVD):
Quality management systems according to the requirements of ISO 9001 and ISO 13485 have been implemented throughout the Institute.
Production of in vitro diagnostic (IVD) medical devices according to EC Directive 98/79 (products are CE marked).
1. Snežana Golubović, MSc, Deputy Director
2. Ljiljana Hajduković, PhD, Senior Research Associate, Associate in charge for Lot Release
3. Slavica Djukić Marjanović, MSc, Associate in charge of Vigilance