FDA has announced an entirely new standard for the identification of medical products. It requires that each medical device be identified using uniquely identifiable device identification (UDI). In the case of implants, such as hip stems or bone plates medical device makers have to identify their products in all ways.
There are numerous reasons for manufacturers to identify medical products. The tools and techniques available to mark medical devices are not sufficient. The laser marking process is a well-known technology used in marking medical devices.
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Manufacturers of medical devices have to comply with the most important requirements for their products like traceability and zero-defect marking. Medical device manufacturers should use permanently traceable and permanent markings to meet several reasons.
Medical devices should be traceable so that they can improve the safety of patients, reduce recalls of products, and increase surveillance of the market.
Product liability: Protection measures against piracy in products and trademark protection to ensure the safety of products.
Identification of the product: This includes identifying the maker as well as the product's production and the product itself
Respect for rules such as those of the UDI directive
Process reliability and quality assurance
If marking content editors should adhere to strict guidelines. Producers need to ensure they have the marks placed on the proper area. These standards outline what is allowed to be placed on the mark (logotypes and 2D codes, or alphanumeric information) and the places it should be placed.
This means ensuring that the right part is being used for marking it and that it's being put precisely where it is supposed to be (mark the exact position).
A wide range of marking content is required by the business such as serial numbers, date codes, lot codes, graphics, images trademark logos, and corporate logos. Complex codes, such as barcodes in 2D, as well as multi-language fonts, are also needed.