Quality & Regulatory

Medax quality management system is certified to ISO13485:2016 standards, in accordance with the requirements of the medical disposable 93/42/CEE directive and its relevant updates. All products undergo intensive clinical testing and are CE and FDA approved.

Focused as it has always been on worldwide markets and with a strong experience in products’ registration processes, our Regulatory department is ready to help our customers’ needs and constitutes a steadfast support during the developing of new and customized products

For any further documents, please contact our Regulatory Affairs at This email address is being protected from spambots. You need JavaScript enabled to view it..

Headquarters: Medax Srl Unipersonale Via S. Pertini, 4 - 41039 - San Possidonio (MO) - Italy
Company direct No. : +39 0535 1812757 - Fax No : +39 0535 1812744 - This email address is being protected from spambots. You need JavaScript enabled to view it. - PEC: This email address is being protected from spambots. You need JavaScript enabled to view it.

Registered Office: Medax Srl Unipersonale Via R. Piva, 1/A - 46025 - Poggio Rusco (MN) - Italy
Vat N. /Fiscal Code N. Iscriz. Reg. Impr.  MN 02669860369 N. REA: MN 233527 - Capitale Sociale Euro 100.011,00 i.v.

In order to meet demanding production and product specifications, Medax’s quality management system is certified to ISO13485:2016 standards, in accordance with the requirements of the medical disposable 93/42/CEE directive and its relevant updates. All products undergo intensive clinical testing and are fully CE and FDA approved.