In vitro diagnostic medical devices (IVDs) are tests intended for examination of human specimens for a medical purpose. In the EU, there is dedicated legislation that manufacturers must follow to produce and sell such devices. The Regulation has significantly reinforced the regulatory framework for IVDs with more detailed and stringent rules on the evaluation of device performance.
A conformity assessment must be completed for the manufacturer to comply with the Regulation and to be able to CE-mark the IVD and place it on the market.
Our society is specialized in the performance evaluation of IVDs under ISO17025 accreditation.
Biotechnology Society composed of an IVD Medical Device Performance Evaluation Laboratory, a Contract Research and Development department, and biomonitoring reagents for wineries and agrofood production follow-up.