Risk Mitigation

The smallest changes to yarn specifications and availability can put you at risk for device revalidation

Anything that affects the supply of a medical component can have a major impact on a medical device company’s bottom line.  For example, some medical textile component providers run the risk of not being able to source the exact same yarn, either due to the yarn supplier changing their specifications or not producing the yarn at all.  And each additional vendor in the supply chain only multiplies potential risks, including:

  • availability of already qualified materials
  • regulatory implications of material changes
  • making sure suppliers are qualified

That’s where we come in

ATEX’s vertical integration provides control and consistency over every aspect of the medical textile, from the yarn specifications through finished component – with one point of contact to manage for the entire component supply chain.