Role Of Laser Marking In Ensuring The Safety Of Medical Device Applications

Medical product identification is required to ensure application traceability and quality assurance. Since the Food and Drug Administration adopted a new rule for medical product identification that requires all devices to be marked with a unique device identifier, original equipment manufacturers (OEMs) demand high-quality laser markings on medical devices.

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Laser marking is the preferred method of marking technology for manufacturers worldwide, with the mark appearing on a wide variety of medical devices such as orthopedic implants and other medical instruments. Laser product marking is corrosion resistant and can withstand processes such as passivation and centrifugation, as well as autoclaving, UV, and gamma irradiation, making them the most effective choice for marking medical devices.

A non-contact engraving form, laser marking provides durable, high-quality laser marking at high processing speeds while eliminating potential damage to the marked part.

Unique identifier

From tubes, shafts, and tweezers to syringes and catheters, the medical device industry is home to a wide variety of curved and complex surfaces that need marking. Your marking must be consistent and accurate to meet strict regulations. Laser marking can add unique identifiers such as part numbers, lot numbers, descriptions, and company logos to various applications.

Manufacturers in the medical market are subject to very stringent regulations, including the latest UDI (Unique Device Identification) and MDR (Medical Device Regulation) standards, which are constantly evolving due to changing patient needs. 

Correct part identification is very important to ensure absolute traceability of the product. Laser marking is the ideal method for making these marks, offering increased production efficiency and cheaper product cuts.