When medical equipment fails, lives are at risk. Every device must be instantly traceable to protect patients and enable immediate action. Direct part marking (DPM) technology provides the permanent identification that makes this critical traceability possible.
Traceability in the medical field enhances patient safety by creating accountability throughout each device’s life cycle. This process allows manufacturers and health care providers to instantly identify devices during emergencies, execute recalls when defects occur and verify authenticity to prevent counterfeit products. The FDA’s unique device identification (UDI) regulations have made traceability mandatory, requiring that medical devices carry permanent, scannable identifiers that can survive sterilization and regular use.
Direct part marking permanently embeds unique identifiers directly onto medical device surfaces using advanced technology like laser engraving, dot peening and chemical etching. Unlike traditional adhesive labels that can peel, fade or fall off, DPM creates marks that become part of the device. These marks remain readable throughout the device’s lifespan, even after sterilization and clinical use.
The FDA’s UDI rule requires medical devices to display a device identifier (DI) that specifies the manufacturer and model. Class 2 and Class 3 devices, which present more risk to patients than Class 1 devices, need a production identifier (PI) that includes lot numbers, serial numbers and expiration dates if applicable. Manufacturers use advanced DPM equipment to permanently mark these UDI requirements directly onto medical devices, creating scannable codes that work with inventory systems and supply chain tracking.
Choosing the proper DPM method is crucial since the marks must meet FDA formatting requirements throughout the device’s service life.
Laser Marking Technologies, LLC specializes in high-quality laser marking systems for UDI compliance in medical device manufacturing. We supply equipment that can produce permanent, high-contrast marks on devices that comply with industry regulations.
Our Cobalt® RX XL laser system sets the standard for medical marking compliance, precision and quality. This high-performance system features cutting-edge Pico and Femtosecond laser technology designed for reliable DPM in medical applications.
Our solutions offer many advantages to medical device manufacturers, including:
DPM isn’t just about meeting regulations — it’s about building trust with health care providers and protecting the patients they serve. When you partner with a reputable company like LMT, you get solutions that deliver compliance, durability and peace of mind. Contact us online or call (866) 799-0199 today to learn more about how our equipment can help with your UDI compliance needs.
