Quality in our activity sector means Responsibility: Vircell fulfills it from the very beginning of the production process, as it is one of the main pillars on which our business idea is based.
At present, the quality of our products is guaranteed by the fulfillment of an exhaustive quality management system, based on a modern and global regulation: ISO 9001. All activities of R&D, Production, Sales and After-sales are audited and certified according to this directive. However and undoubtedly, our biggest satisfaction is the confidence that laboratories from any part in the world put in us every day.
Since 2022, in vitro diagnostic reagents must incorporate the CE marking by complying with REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 5, 2017 on medical devices for in vitro diagnostics. Vircell works continuously to comply with this regulation. In 2023, Vircell was granted the ISO 13485 certification by the notified body TÜV SÜD, which certifies our quality assurance system.
Moreover, the company is implementing a global adaptation system to GMP regulation, necessary to obtain the FDA approval.