Medical technology requires close attention to safety and sensitivity in the manufacturing of products.
With us, this is achieved by having reproducible and validated processes, complete lot traceability and comprehensive production documentation.
As a medium sized, family-owned business, we see ourselves suited to fulfill the increasingly complex medical regulations on the one hand and on the other to maintain speed, flexibility and transparency
during the realization of our surgical tools and implants in a globalized market.
We focus on:
- Development support concerning economical manufacturing, functionality and cleaning capabilities
- Product management with project leaders as contact partners
- Manufacturing according to ISO 13485 and FDA 21 CFR Part 820 with qualified assets and validated processes
- Prototype manufacturing , per request based on 3D models
- First series manufacturing including initial sample inspection reports
- Seriens manufacturing through automated and controlled machinery
- Quality control trough random sampling or 100%-testing, manually and with our 3D coordinate measuring machine
- Large in-house surface finishing facilities, including deburring, age hardening, blasting, electrolytic polishing, laser marking, passivating, cleaning and assembling of instruments
- Cleaning using automated ultrasonic cleaning devices with monitored parameters
- Authorized subcontractors for processes like welding and coating
- Documents like material and hardening certificates, test reports and Device Master Records (DMR)
In the field of surgical instruments:
4in1 tibial cutting blocks, femoral impactors, tibial impactors, sizing guides, cutting tools, drill guides, trial implants
cup impactors, shaft setters, rasps
pedicle-screw systems, socketed grub screws, anchor screws, counterholders
ankle clamps, shoulder mills, protection sleeves