Medical devices are extremely critical to produce to exacting standards. Reproducible, traceable examination and dimensional measurement of key items to specified tolerances play a major role in ensuring the reliable and repeatable performance required. Due to the high item cost, it is imperative to avoid rejection of lots or batches.
The quality of raw material and components also needs to be certified prior to release from incoming inspection in order to provide a complete audit trail for regulatory purposes.
Among the main customer requirements, we have experienced the need to avoid destructive testing of expensive prototypes and unique implants, reduction of lengthy dimensional inspection processes of complex shapes with comparison to CAD and the performance of automated measurements for high volume production.
Another added benefit from the LK Metrology product portfolio is high performance reverse engineering supported by the application of non-contact laser scanning. For some medical components, such as knee or hip implants and hearing aids, the shape of the component is crucial for fast patient recovery and maximum comfort. LK Metrology‘s software and sensor solutions are a well established benchmark in this specialty segment.