The Medical sector has to respond on many requirements in respect of hygiene, quality and safety. Guaranteeing patient safety, these numerous constraints are more and more governed by standards, which are essential for the implementation of effective traceability processes.
In 2013, the FDA (Food and Drug Administration) set up the UDI marking (Unique Device Identification) which aims to identify all medical components, from their manufacture to their use by the final customer. This standard is also imperative for the export of surgical components to the United States. The European Union has recently adopted its own standard through the MDR marking (Medical Device Regulation).
The UDI marking is composed by two unique identifiers:
The elements to be marked are as diverse as the professions that make up the medical sector. For example, there are many cases of marking on instruments, such as scalpels, which are an essential tool used in many surgical procedures. But also bone prostheses, made of steel, cobalt, ceramics or biomaterials, dental implants, often made of titanium, or hearing aids.
Directly applied on medical components, UDI markings face various constraints linked to the complexity of the devices to be identified, making a real technical challenge of traceability in the medical sector.
These difficulties could be:
SIC MARKING, the traceability leader for more than 30 years around the World, proposes its perfectly adapted laser marking solutions to UDI standards. This technology, highly regarded in the medical sector offers many advantages:
The SIC MARKING laser product range meets your needs, regardless of the type of marking required or the production environment (serial or single-unit). It consists of lasers that can be integrated:
Different marking machines:
As well as numerous options:
SIC MARKING manages the customer’s needs, and gives personalised support throughout the project and has many references in the medical sector.
Submit your marking project to us, we will probably have manufactured a similar solution in our many years of experience in the medical sector allowing us to offer you a proven and validated solution. Our technical teams will also be able to Project manage a bespoke custom solution for you that will fit perfectly into your manufacturing process.