The FDA along with other regulatory bodies continue to exert regulatory pressure on OEM’s and Contract Manufactures supplying completely machined products or components to the most demanding industries. A common area of scrutiny is the requirement to maintain material traceability for the life of the device. Material traceability (and other critical supply chain and process information) is recorded and maintained in a document package named the Device History Record (DHR).
A key element in our risk mitigation system is the ability to track raw material to its melt source and all the way through the manufacturing process.
While the vast majority of material suppliers strive to provide 100% traceability to the melt source, few offer the capability of physically marking and labeling each piece of material in addition to providing the material certifications of compliance required. For round bar and flat type material, this process is known as “Line Marking.”
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