Gravotech - Traceability of medical devices

Identification & Traceability Of Medical Devices

Learn more about our medical devices laser marking machine!

Gravotech laser marking machines are ideal for laser marking on medical devices, prostheses, and other surgical instruments. The UDI (Unique Device Identification) standard requires manufacturers to mark their production of medical and surgical equipment that they produce for the United States.

The European Union quickly followed with the MDR standard (Medical Device Regulation). The EU also requires that all medical and surgical instruments are identified before manufacturers export them in any European Union country. As an expert in traceability marking solutions for more than 30 years, Gravotech supports UDI and MDR compliance.

Traceability Of Medical Devices

Datamatrix mark on a scalpel

Laser marking on medical equipment enables you to get permanent marking resistant to sterilization processes. This traceability system can engrave logos, Datamatrix codes, serial numbers, or any other information required to identify a medical device. Manufacturers in the medical market and healthcare institutions are regulated by very strict regulations, including the latest UDI (Unique Device Identification) and MDR (Medical Device Regulation) standards.

Medical items engraved with laser marking machine

Fiber, Green, and Hybrid lasers are the most suitable solutions for your medical device identification requirements. They are available in marking stations, or in a production line integrable versions. Always attentive to better meet your needs, Gravotech provides you with the best-suited solution for your production type. Do you want to make individual marking or small and medium series? Laser marking stations are the solutions that best suit your needs. If your production requires the marking of large series, we recommend our integrable lasers on your production line.

Close up of a clamp marking

SECURITY
To identify any medical or surgical device without any risk of bacteria installation, Gravotech laser marking machines are the perfect. We provide you with a safe and efficient identification process.

COMPLETE IDENTIFICATION
Do you want to ensure full traceability of your medical or surgical device and fight counterfeiting? Laser marking machines are what you need

STANDARD COMPLIANCE
Forget polluting and expensive labels thanks to laser marking, a reliable alternative to meet the identification and traceability standards for medical devices (UDI and MDR).

QUALITY
The markings made by our laser engraving machines are detailed, precise and sustainable on any surgical instrument or medical equipment.

Different medical equipments engraved

Gravotech laser marking enables you to obtain optimal results and has many benefits, including, Permanent, sustainable and tamper-proof markings, Complies with UDI (Unique Device Identification) and MDR (Medical Device Regulation) standards, Resistant to sterilization processes, contact with acids, heat and time, Uniform marking on all types of parts, regardless of their complexity, Laser marking does not dig or alter the material (stainless steel, polymer, titanium, etc.), which does not compromise the cleanliness of the medical device, and finally, Easy proofreading of markings

Identification Of Titanium And Stainless Steel Medical Prostheses

Unique Device Identification on prostheses

Their purpose is to partially or totally replace a bone in the human body. They must therefore be very resistant. For this reason, the most commonly used materials are metal, ceramic or highly cross-linked polyethylene. Mark a reference number and logo on each prosthesis based on alphanumeric series retrieved from a dedicated database. There are around 600 prosthesis references concerning different materials and shapes. Cycle time under 1 minute, and Adaptation of the marking parameters based on the material and shape without the need for intervention from the operator on the marking file (operator mode). High Contrasted, non-destructive marking that has to meet laboratory controls and validation standards.

Prostheses indentification with datamatrix code

The marking of medical equipment can be done by laser, a marking technology that is highly appreciated in the medical field because it has many advantages. Laser marking on medical instruments is permanent and contrasted. The most common solution to meet the traceability requirements of prostheses is annealing. This marking technique consists in locally heating the material (titanium, stainless steel, etc.), which makes it possible to obtain a highly visible and readable marking. The advantage of annealing is that it is non-abrasive, the etching is carried out on the surface, which means that the part is not damaged, and thus avoids contamination from bacteria. Gravotech laser engraving machines can be used to mark different medical materials, thus meeting many market applications and requirements, including UDI and MDR standards.

Prostheses indentification with datamatrix code

The operating software has flexibility built-in, allowing for customer-specific customization. In this case, each prosthesis is marked with very specific reference numbers and logo. After initial set up, the software automatically runs the correct sequence. This reduces the chance of any operator error. The operator’s only programming obligation is inputting a part’s measurements and material type. This can be done manually or use a hand-held barcode scanner. Then, after placing the prosthesis in the marking chamber, activate the marking program with the push of one button.

Discover Gravotech’s Solutions

Our laser marking machines are ideal for identification on medical devices, prostheses, and other surgical instruments. Lasers are the technology of choice for the medical industry to comply with the FDA and MDR requirements to mark all medical tools and devices with a unique device identifier (UDI).