add'n solutions is a service company in Tuttlingen for all quality-relevant steps following the production of surgical instruments and other medical devices: quality control, laser marking, cleaning and passivation through to sales-ready packaging and labelling, in a cleanroom on request. The company grew out of work on the UDI directive — and the decision to take marking into its own hands with its own laser.
For UDI implementation a process was developed that ensures marking in accordance with all FDA and MDR requirements; the applied 2D DataMatrix codes are verified to ISO 15415 and ISO/IEC TR 29158. Final cleaning and passivation to ASTM A380 and A967 take place in a fully automatic, validated system. Together with the laser manufacturer FOBA, add'n solutions has published the first long-term study on laser marking.
Quality management is certified to DIN EN ISO 13485:2016; processes and results are continuously tested and documented. A free collection and delivery service covers Tuttlingen and the surrounding communities.
