At EuroClone Diagnostica, all manufacturing procedures involving diagnostic reagents are strictly regulated, with raw materials, bulks and final products undergoing stringent controls.
The different production areas are classified in order to ensure the most appropriate cleanliness level to each particular production step. The overall quality of the entire process is guaranteed by means of adequate SOPs and specific training of the personnel working in the Department.
Whenever possible, the processes are automated in order to meet both our internal standards and market’s requirements. Smaller production units, yet operating under the same regulations, are able to manufacture customized products which exhibit the same quality level achieved by standard production.
EuroClone Diagnostica is committed to provide complete solutions to routine laboratories’ needs. To this end, EuroClone develops and manufactures molecular biology based IVD-CE products dedicated to several diagnostic areas, such as: genetic diseases, infectious diseases, viral load, automation of DNA/RNA extraction and PCR set up.
EuroClone Diagnostica manufactures several reagents that are successfully used in a number of research and diagnostic labs and CE-IVD marked Molecular Diagnostic kits.
EuroClone Diagnostica and its Production Department, is certified: ISO 13485:2012. that specifies requirements for a quality management system, for an organization that has to demonstrate its ability to produce and provide medical devices.
ISO 13485:2012 consistently ensures to meet customer and regulatory requirements, applicable to medical devices and related services.