High demands in medical technology
The medical technology sector focuses on sustainable improvements of the quality of life. Therefore absolutely reproducible processes with gapless traceability of the manufacturing chain - including batch verification and proper documentation in line with regulatory standards - are essential. In precision injection moulding and assembling of small parts and micro-components Toolcraft processes with highest dimensional accuracy (down to 0.01 mm or <0.4 mil) in series production, with accurate surfaces and high purity.
Certification according to EN ISO 13485:2012 + AC:2012 - certified quality
With the certificate the certification authority DEKRA attests Toolcraft an extensive quality management system according to the process-oriented standard of EN ISO 13485:12 + AC:2012. Based on the structure of DIN ISO 9001 it includes additional specific requirements of the medical technology sector. Due to the standard's conformity with applicable EU directives the certification forms the basis for future international projects at Toolcraft.