The identification of medical devices is necessary to ensure traceability of applications in addition to quality assurance. The Food and Drug Administration adopted an updated rule for medical product identification, which demands that all devices be identified by a unique device identifier OEMs are required to use laser markings on medical appliances.
The laser marking method is the primary method for marking technology used by manufacturers around the world as the mark appears on a variety of medical devices like orthopedic implants as well as other instruments for medical use.
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Laser markings are resistant to corrosion and can be able to withstand processes such as centrifugation and passivation, along with autoclaving, UV, as well as radiation from gamma, making them the best option for making marks on medical instruments.
A non-contact form of engraving laser marking offers quality, durable laser marking with high processing speeds while avoiding the possibility of damaging the marking portion.
Unique identifier
The medical device sector is home to a wide range of curved and complex surfaces that require marking, from tubes, shafts, and tweezers to syringes and catheters. To meet tight rules, your marking must be consistent and exact. Laser marking can be used to add unique identifiers to a variety of applications, such as part numbers, lot numbers, descriptions, and business logos.
Manufacturers operating in the medical industry are subject to extremely strict regulations, including the most current UDI (Unique Device Identification) and MDR (Medical Device Regulation) standards that evolve constantly in response to changes in the needs of patients.
The correct identification of parts is essential to ensure the accuracy of traceability. The laser marking method is the most efficient method of marking these parts that can increase the efficiency of production and lower cost cuts to the product.