Implant-manufacturer sites meet ISO 13485
MediTech Medical Polymers, a manufacturer of polymers for orthopedic implants, says its U.S. and U.K. manufacturing operations have been certified to ISO 13485:2003. The Fort Wayne, Ind.-based company (meditechpolymers.com) says its manufacturing operations in Germany have been reviewed to the ISO standard and formal certification is pending. ISO 13485 is the 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's US operations are already ISO 9001:2000 compliant.
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