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Amada Miyachi Blog

Are you on track for meeting UDI requirements?

Posted by Geoff Shannon on Tue, Mar 22, 2016 @ 12:30 PM

By now, most of you are at least vaguely familiar with the landmark law that gradually phases in the requirement for manufacturers of medical devices to place unique device identification (UDI) marks on all of their parts. Are you on track for meeting the deadlines for the direct marks that are required?

The comply-by timeline depends upon the type of product being made and method of marking employed. On September 24, 2015, we reached the first real milestone, which was for Class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices. Take a look at Table 1 for an overview of deadlines for providing permanent marks on all device classes:

UDI_Blog_Table_1.jpg

Of course, even before these mandated UDI marking requirements, many manufacturers used direct laser part marking for alignment and depth aids as well as to apply logos and part numbers. Manufacturers like the dark mark the laser produces on stainless steels and titanium because it provides visibility from all angles, avoids removing material that could present sites for contamination, and projects a certain level of product quality to the end-user.

Before you select a laser marker, however, be sure to do your homework. You will want to make certain you are selecting the correct laser source to make the required mark on the part to ensure stability in everyday production and avoid potentially substantial costs associated with an unstable mark including inconsistent yields, re-working parts, missed delivery schedules, and constant process tinkering.The right laser and a stable process saves labor costs, and provides consistent output that you can plan for and count on.

Topics: laser marking, UDI

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