Nanoplasmas develops, manufactures and distributes high end diagnostics that meet National and International Standards and Regulatory Requirements. Nanoplasmas continuously monitors and improves its Quality. Nanoplasmas products are manufactured in Medicon S.A. following all regulatory requirements. Nanoplasmas has developed a Quality management system, which was certified by National Evaluation Center of Quality & Technology in Health S.A. – EKAPTY. The quality management system is following: A. EN ISO 13485:2016 as the result of the Annex B of ISO13485:2016, as well as the Council Directive IVDD 98/79/EEC Annex and European Regulation for in-Vitro Diagnostics Medical Devices and B. EN ISO 9001:2015 for the Quality management. Our customer support department is continuously monitoring its products performance and the customer satisfaction and implements any improvements required to prevent any nonconformity and ensure customer satisfaction. The Greek National Organization for Medicines (EOF) approval number for the Nanoplasmas SARS-CoV-2 molecular detection kit for human samples is 2830000746596.
Nanoplasmas Management Team