Quality & Regulatory

Medax quality management system is certified to ISO13485:2012 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 Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo..

Headquarters: Medax Srl Unipersonale Via S. Pertini, 4 - 41039 - San Possidonio (MO) - Italy
Company direct No. : +39 0535 1812757 - Fax No : +39 0535 1812744 - Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo. - PEC: Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.

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 ISO13485:2003 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.