PRIMA Lab is a certified Company according to ISO 9001:2015 "Requirements for quality management systems" and ISO 13485:2016 "Quality management systems - Requirements for regulatory purposes of medical devices". These allow our organisation to operate, in all business processes, according to the highest international quality standards, demonstrating the commitment of Prima Lab in offering products and services aligned with the state of legislative and regulatory art, through the application of organisational models tested and aimed at continuous improvement.
In particular, the ISO 13485 standard specifies the requirements for a Quality Management System that allows us to demonstrate our ability to provide IVD Devices and related services that comply with customer requirements and regulatory ones applicable to medical devices, like the European Directive on IVD 98/79/EC.
What are the main advantages?
For Companies that distribute or sell PRIMA Home Test products: secure and constant supply of products that comply with current regulations.
For users, customers and patients: products safety and reliability and services offered.