HELP (Holistic Enhanced Laser Process)

Lasers are used in different ways for processing medical devices. Laser marking machines with integrated vision systems emerged as an effective means of identifying medical components, e.g. for marking UDI compliant codes.

Innovative laser technology has become the preferred solution for marking medical devices as it enables medical device manufacturers to overcome marking challenges.

Particularly zero-defect laser marking plays an increasingly important role in manufacturing medical devices since the FDA (Food and Drug Administration) requires that, by 2016, every medical device in the USA contains a 2D code for traceability. The key to meeting the FDA identification requirements while reducing production costs, minimizing waste and improving product quality is a laser marking system combined with the software concept HELP (Holistic Enhanced Laser Process).

Apart from the marking of the medical product itself, HELP offers pre-mark verification prior to marking and post-mark validation right after marking. Particularly important for medical device manufacturers: During the unique post-mark verification process, the content of 1D and 2D codes (e.g. Datamatrix [ECC200] GS1 compliant and graded) can be directly read which is indispensable for compliance with the new Unique Device Identifier set by the FDA.

Analysis and opinion

By Dave MacLellan, Executive Director, AILU


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