Medical Traceability
Low impact surface
No hygiene traps

Our 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, 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 for which 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. We use our lasers to deep-etch this hard-to-process material with user information and CE marking.