Medical Devices With Laser Marking

FDA has established a new rule for identifying medical products. It requires that every medical device be identified by a unique device identifier (UDI). When it comes to implant devices such as bone plates or hip stems, medical device manufacturers must mark all of their products.

There are many reasons for manufacturers to mark medical products. The tools and technologies that are available for this purpose are limited. Laser marking is a very popular technology for marking medical devices.

If you are in search of a medical device laser marking service you may hop over to protolase.com/marking.

The Benefits of Laser Marking Medical Devices - Laser Impressions Inc.

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Manufacturers

Manufacturers of medical devices must adhere to key product requirements, such as traceability and zero-defect marking. Medical device manufacturers must use permanent and traceable markings for a variety of reasons.

  • Medical devices must be traceable to improve patient safety, minimize product recalls, and maximize market surveillance.

  • Product liability

  • Protective measures against product piracy and trademark protection for product safety

  • Product identification: This involves identifying the manufacturer, the production, and the product itself

  • Respect for regulations such as the UDI directive

  • Quality assurance and process reliability

When marking content, producers must follow strict guidelines. Producers must ensure that the mark is correctly placed on the correct part. These standards define what can be marked (logotypes or 2D codes or alphanumeric contents) and where it must apply.

This includes ensuring that the correct part was used to mark it and that it is being placed exactly where it should be (mark positioning).

A variety of marking contents are required by the industry, including serial numbers, date codes and lot codes, images and graphics, trademark logos, and company logos. Complex codes such as 2D, barcodes, and multilanguage fonts may also be required.