Along with the daily progress made in the Healthcare industry and science the medical devices evolve very quickly and become more and more sophisticated.
As a given those devices must meet the quality and safety requirements necessary to guarantee patient health and safety .
Their design and manufacturing require multiple technologies and processes, which call for deep expertise and know-how.
AXE develops and manufactures medical devices from start to finish in the product design life cycle.
In case of audits and inspections performed by notified bodies or national authorities, a special attention as we know is paid to the manufacturing process
Axe is regularly audited and inspected and make sure his quality system remains always up to date and compliant
Certification according to ISO 13485 is one of the commonly used selection criteria. Therefore AXE is very proud to be certified by the LNE/G-MED bodies which are highly regarded in their domain of expertise