MediTECH Medical Polymers achieves ISO certification April 18, 2008|
MediTECH Medical Polymers, Fort Wayne, IN, a manufacturer of polymeric materials for orthopedic implants, has announced that its 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 US FDA's good manufacturing practices. 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, says the company.
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