Medical Laser Marking
Traceability solution - Low impact surface - No hygiene traps
Our laser marking services for medical devices comply with the same two sets of device-specific legislation used in the EU and the UK:
– European Union law, The Medical Devices Directives and Regulations
– UK law, The Medical Devices Regulations
FIMARK has been working in the medical industry since 1999 offering high contrast, permanent marks to the manufacturers of implants and medical devices and instruments. Laser marking is used so that low impact surface marks can give traceability to components without creating hygiene traps.
The marking needs to withstand autoclaves and passivation and to be sufficiently permanent so that implants can be traced back to manufacturer and material batch if they fail in use. Many implants need to be marked on curved surfaces and the non-contact properties of laser marking are ideal.
Where a surgeon has many different sized implants to choose from, the marking needs to be clear and bold for ease of selection in theatre. The high contrast marks achievable with a laser are essential for these critical environments.
Recently FIMARK has been working with a supplier of graphite bone drilling jigs. Our lasers are used to deep etch this hard to process material with user information and CE marking.
Quality and On-time delivery
Fimark ensures a high added value on all our processed components and guarantee excellence in quality. We can also offer additional services including faster turnaround, short term storage and delivery management.
Our operations management processes enable constant production reliability and ensure high quality control. This process involves five different stages using different quality devices ensuring items are fit for the purpose for which they are intended. Fimark operates and complies with the two medical sets of device-specific legislation used in the EU and the UK. If your order has to be processed faster than the usual turnaround we can often offer you a quicker solution.
Our storage and delivery management process can be tailored to your needs. We can have your goods delivered anywhere in Europe and, if needed, we can provide a short term storage solution in our facilities.