Manufacturing in the health care sector is going through a big change. Supply chain traceability and individual device identification is of high priority and that affects the ways of manufacturing. The new Medical Device Regulation (MDR) sets the new standard for the industry. The MDR was published on May 5th 2017 and came into force on May 25th 2017. Manufacturers are going through a transition time to meet the requirements of the regulation. The transition deadline is May 26th 2021. One of the absolute key points of the new regulation in the European Union is the implementation of Unique Device Identification (UDI). It mandates the use of a UDI mechanism. This enables the manufacturers and authorities to trace devices with a potential safety risk.
Likewise, consumer electronics require regulated markings in the products. For instance, the CE mark is a requirement for all the products sold within European Union. Other markings manufacturers use are for example manufacturer identification (logos and trademarks), model identification (number and name) and individual unit identification such as serial number, QR code, date and batch code etc. These markings should be clear and readable throughout the natural life cycle of the product enabling identification and full internal and external traceability from prototype to end customer on the market.
Medical devices and consumer electronics use a wide material base. However, from a laser marking technology point of view, they are typically relatively easy to mark. Cajo can help assess how challenging the materials are for laser marking – How well does the laser work together with the materials to be marked? This is done through Cajo’s laser specialist team in our evaluation process. (Book a free demo) The outcome will be functional marking parameters for specific materials. The customer will receive a proof of concept even before the decision. That is why Cajo is a safe partner when selecting a marking solution provider.
Sometimes the marking environment for products is a cleanroom type environment. Cleanroom classification is done by measuring the number and size of particles permitted per volume in the air in the space. Cajo’s laser marking solutions support cleanroom markings with a fume extractor solution and connectivity to a customer’s general system for dust and particle removal. Automation of marking solutions and cells are also in huge demand within the industry. Cajo’s software products and software interfaces support the integration between any device and software. This enables a fully automated, effective production process with high-quality permanent laser markings.
Cajo is able to provide solutions to meet the high standards of manufacturing efficiency. The Cajo laser marking solution platform enables a high level of integration in the production environment through flexible design. This enables manufacturers to utilize Cajo solutions to their full potential. Typically, customer needs to integrate the Cajo laser marking solution with their existing ERP system or other databases for fetching the marking content for the laser. Cajo software solutions support integration enabling flexible operation. The Cajo laser marking solutions is proven to have reduced cycle time for marking. As an example, a medical device manufacturer operated with an old marking technology with a cycle time lasting for minutes. When replacing the old solution with a Cajo laser, the marking time was reduced to seconds. That is what we like to call efficiency!
Medical devices need to be safe to use. To ensure patient safety, the healthcare and medical device industry is heavily regulated by the Medical Device Regulation (MDR). To reach compliance, all medical devices must be properly marked for Unique Device Identification (UDI) and be certified with appropriate CE markings.
As an expert in permanent laser markings, Cajo Technologies has been instrumental in helping Medical Industry manufacturers produce fully compliant and traceable products.