MediTECH® Operations Now Meet ISO 13485
Superior products begin with superior raw materials. MediTECH uses GUR® premium resins from Ticona, specified for use in surgical orthopaedic implant applications. This highly pure resin complies with standards ASTM F648 and ISO 5834-1, and exhibits excellent biocompatibility with skin, blood and tissue. Even so, the resin undergoes rigorous testing prior to use in the manufacturing process. We have instituted a series of tests and implemented quality control measures to produce converted materials that far exceed ASTM F648 and ISO 5834-2 requirements. MediTECH’s U.S. operations are certified to ISO 13485 and ISO 9001. Our U.K. operations are certified to ISO 13485 and our German operations are certified to ISO 9001 with ISO 13485 pending. MediTECH’s manufacturing approach is based on a cellular manufacturing system that incorporates all processes, from resin handling to extrusion and compression molding, annealing/heat treating, finishing and packaging. These self-contained environments, combined with systems such as closed loop resin handling, eliminate the introduction of contaminants to insure we provide the cleanest product to the industry. Utilizing MediTECH’s skilled personnel and highly refined processes within these manufacturing cells, we insure that both Chirulen® and Extrulen® are the most consistent, high quality products available for use in your applications.