Fort Wayne, IN — MediTECH Medical Polymers announced that US and UK manufacturing operations have been certified to ISO 13485:2003. Manufacturing operations in Germany have been reviewed to the ISO standard and formal certification is pending.
ISO 13485 is the international quality management standard for designers and manufacturers of medical devices and related services, and is harmonized with the U.S. FDA's good manufacturing practices.
MediTECH has actively pursued this certification as part of an ongoing commitment to achieve compliance with regulatory requirements in response to the needs of the medical community at a global level. In addition to the standard specific to medical devices, MediTECH’s US operations are ISO 9001:2000 compliant.
MediTECH uses a highly pure resin that itself complies with standards ASTM F648 and ISO 5834-1, and exhibits excellent biocompatibility with skin, blood and tissue. Additionally, the resin undergoes 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 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.
Filed Under: Materials • advanced