21 - 23 Jun 2022 International trade fair for laser material processing
11.02.2020 - 15:39

New Medical Device Regulation: TRUMPF helps combat product piracy

High-technology company TRUMPF is offering extensive support to medical device manufacturers to help them meet the challenges of the new European Union Medical Device Regulation (MDR), which comes into force in May 2020.

Under the MDR, medical devices and manufacturing processes will be subject to stricter rules. “Drawing on our experience as a machine maker and system integrator, we can help medical device manufacturers meet all the new requirements without any hassle – so they can get on with the important job of running their business,” says Klaus Löffler, managing director and head of sales and service for TRUMPF’s laser technology business, speaking at the Medical Photonics in-house technology conference at TRUMPF’s headquarters in Ditzingen.

“We have the solutions to beat product piracy”

The new MDR places a particular focus on the unique device identification system launched by the U.S. Food & Drug Administration (FDA). This global identification system requires all medical devices to have a unique device identifier (UDI) that ensures full traceability along the entire supply chain. Every medical device must be permanently labelled with a UDI code in both easily readable plain text and in a machine-readable form to ensure that the product can be checked against its entry in the FDA-administered Global Unique Device Identification Database. TRUMPF offers an all-in package to help medical device manufacturers meet these requirements. “We provide the customer with a system that is not only equipped with the most suitable marking laser for their particular devices, but that also features the appropriate image processing software,” says Löffler. This includes a sensor system which customers can use to generate, apply and read UDI codes, thereby satisfying all the requirements of the MDR. “We offer the perfect way to beat product piracy, boosting people’s confidence in manufacturers that opt to use our lasers in their production process,” says Löffler. TRUMPF uses a “black marking” process that generates an extremely dark, high-contrast mark. This solution is particularly suitable for surgical instruments since it offers excellent corrosion resistance. The instruments can be cleaned and disinfected several times a day without showing any signs of corrosion. “The laser is the only tool that can create that kind of marking,” says Löffler.

Artificial intelligence to analyze production in the future

From endoscopes and ophthalmic forceps to stents and pacemakers, medical device manufacturers need reliable and consistent manufacturing processes that allow them to produce high quality devices more efficiently. TRUMPF offers production, digitalization and validation solutions that meet the requirements of the new Medical Device Regulation. As well as digital services for production processes including welding, cutting, marking and structuring, the company also offers predictive maintenance, continuous tracking of condition data, and storage of quality data. “We help our customers monitor their entire production process, which ultimately translates into greater safety for patients. Our sensors show manufacturers how efficient their production processes are and where they could be improved,” says Löffler. The next level of intelligent sensors based on artificial intelligence are already being rolled out, he adds. In future, these systems will pave the way for even more detailed analysis of sensor data, leading to even bigger improvements in production and quality assurance processes.

Train, calibrate, document

The equipment and process validation rules under the new MDR apply to machines and processes used to produce medical devices. TRUMPF is working closely with its customers to ensure everything is properly verified and validated. This includes various test certificates, measurement processes and verification steps as well as the introduction of specific documentation guidelines. “We offer training, calibration, documentation, system check-ups and regular servicing and maintenance. We have years of experience with a wide range of production processes. That makes us the perfect choice to help customers get their equipment and devices validated quickly and easily and help them keep their manufacturing process stable and robust over the long term,” says Löffler.


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