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In January 2023, GeneProof was one of the first companies in Europe to obtain the EU Quality Management System Certificate according to the European IVDR regulation.
In January 2023, GeneProof was one of the first companies in Europe to obtain the EU Quality Management System Certificate according to the European IVDR regulation. GeneProof is now launching its first IVDR kits and offers its customers an unbeatable advantage of working with cutting-edge products that are in line with the demanding requirements of European legislation for in vitro diagnostics. The first IVDR kits are being manufactured for the Czech and Slovak market.
For GeneProof, producing and offering products in compliance with the (EU) 2017/746 Regulation (IVDR) represents a major milestone with the promise of continued success in the future. The IVDR certification process was challenging and required a large investment of resources and finances. GeneProof can now offer the first IVDR kits from the Immunocompromised-Transplanted Panel (CMV, EBV, VZV, HSV), with more to come in the future.
"The new European Union legislation for in vitro diagnostics has set strict rules for manufacturers and laboratories working with these medical devices. That is why there is great demand for our GeneProof PCR kits on the European market. High quality is also the reason for the increased demand from marketing outside of the European Union, and we are proud to be able to satisfy our customers´ needs. However, the first IVDR kits are initially being manufactured for the Czech and Slovak markets," adds GeneProof Sales Director Tomáš Mohelský.
GeneProof, a leader in molecular diagnostics, today announced the addition of six new IVDR-certified PCR kits…
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