The new Medical Device Directive - MDR for short - focuses in particular on the Unique Device Identification Code (UDI) introduced by the U.S. Food and Drug Administration (FDA), a globally uniform marking system. According to this system, all medical devices must be labeled uniformly so that they can be traced seamlessly along the entire supply chain.
This code must be machine-readable, in plain text and permanently affixed to every medical device so that the product can be matched with a master data entry in a central database.
Trumpf offers a complete package for medical technology manufacturers for this requirement. "The customer receives a system from us that is not only equipped with the marking laser best suited for his products, but also with the necessary image processing software," explains Klaus Löffler, the Managing Director responsible for sales and services in laser technology at Trumpf. "This also includes sensor technology with which the customer can create, apply and read out the UDI code. In other words, everything that the MDR regulation requires of him. In this way we put a stop to product piracy and ensure trust in those manufacturers who produce with our lasers.
The so-called black marking leaves an easily recognizable, deep black marking and is particularly interesting for surgical instruments. Such a laser marking on a medical instrument is corrosion-resistant. The instruments can be cleaned and disinfected several times a day without showing corrosion. "Only the laser is capable of making such markings," Löffler continues.
Be it endoscopes, eye tweezers, stents or cardiac pacemakers - manufacturers need reliable and reproducible production processes in order to produce medical technology efficiently and in high quality. Trumpf offers suitable production, digitization and qualification solutions in view of the new medical device regulation. The digital services for the production processes welding, cutting, marking or structuring include continuous status data acquisition, quality data storage or predictive maintenance. "This enables us to offer our customers complete monitoring of the production process and thus ensure greater safety for the patient," says Löffler. "Our sensors provide information on performance and show possibilities for improving it."
The next stage of intelligent sensor technology has also already been initiated with artificial intelligence. With their help, sensor data can be analyzed to such an extent in the future that production and quality assurance processes can be improved enormously.