Laser Marking Solutions in medical industry for medical devices identification, patient health, medical implants, counterfeiting issues, drug safety, compliance with regulatory standards and privacy
All the medical devices, surgical tools and instruments, medical implants and pharmaceutical companies and manufacturers Faces challenge of Identification.
Identification of these medical devices has become increasingly important because of strict FDA (Food and drugs association directives) To export the medical devices and equipment to United states the devices must be marked following UDI directives and standards. And To export the medical labware and surgical instruments to the European Union the exporters and manufacturers need to follow all the traceability MDR standards and compliances.
Markolasers UDI MED Laser marking machine is an ideal laser marker for product identification of the medical and surgical instruments. The laser marking process is complete a permanent and non-contact process. Markolasers UDI MED laser marker is specially designed for marking on medical equipment keeping all the medical standards in its configurations. It offers consistently high contrast and high-speed marking which reduces the production time and eliminates any potential damage or strain on the tool being marked. The laser marking process is one of the preferred methods of identification of medical devices.
According to UDI Laser marking standards, the laser marking must be corrosion resistant and must withstand processes such as passivation, autoclaving and centrifuging which is also known as Sterilization 35+ years of experience in medical traceability and laser marking. Constant development in Laser application R & D lab and experienced technical service and support team will help you and support you in every stage where UDI, FDA, and MDR compliance are kept in mind. Indelible Laser marking of serial code, traceable 2D-Datamatrix code, QR code, bar codes, Compliance and regulation logo or symbol marking, batch code number, branding on medical devices like a logo or artwork marking.
Clean and clear visibility and Comfortability readable marking of medical devices is technically called as Laser annealing. Titanium and titanium alloys, Stainless steel, mid or High-alloy steel, Coated or painted metals, Ceramics, Plastics or composite plastics (i.e PEEK for implants).
The laser annealing process is a non-abrasive process, the laser etching is carried out directly on the surface, which avoids bacterial and viral contamination.
Surgical instruments & equipments
Serializations or traceability of Surgical Instruments like Scissors, Forceps, Clamps, Needle Holders, Knives, Blades, Retractors and Fiber Optic Headlights is essentially demanding for Manufacturer.These instruments are made up of metals and plastic. Markolaser helps all the surgical instrument manufacturer by providing them Med Laser marker which is designed and configured according to UDI, MDR and FDA Standards and regulations.
Branding and UDI data matrix on Medical Peek and Orthopedic or trauma surgery implants
Trauma fixation PEEK is generally fabricated into bone plates, nails, anchors and screws. Orthopedic PEEK is one of the best replacement for metal while undergoing orthopaedic procedures, and particularly knee and hip arthroplasty. Dental PEEK, Cardiovascular peek, prosthetic peek, Hip-ball, Hip-stem, Bone screw all these peek require traceability.
Bone prostheses is the potential replacement of bones completely or partially. These bone prostheses are made up of substrates like non-reactive and non-corrosive metal, ceramic or highly cross-linked polymers. Whether they are metals like zircon or titanium, plastics or any polymer like polypropylene and acrylic they must follow all the medical compliance for traceability.
Key benefits of MTRACK traceability software solutions