Certification according to EN ISO 13485:2012 + AC:2012

Toolcraft receives certification for manufacturing of medical products according to customer specification
2-components-machine (PresseBox) (Georgensgmünd, ) Toolcraft maintains high standards of quality assurance and environmental protection. This is documented by several certifications and awards. Since March 2014 the company also meets the standard of EN ISO 13485:2012 + AC:2012. The certificate attests Toolcraft an extensive quality management system for manufacturing surgical tools according to customer specification.

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.


MBFZ toolcraft GmbH
Handelsstraße 1
D-91166 Georgensgmünd
Tina Hartmann
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