Medalist plant receives ISO-13485 certification

 The compounding plant where Teknor Apex Company produces the Medalist? range of medical elastomers is now certified under the international ISO-13485 standard for quality management in medical manufacturing, according to the company’s Thermoplastic Elastomer Division. ISO- 13485 specifies systems for consistent compliance with regulatory and customer requirements and includes provisions for risk management, sterile manufacturing, and traceability. “The comprehensive implementation program required for ISO-13485 certification has focused our entire St. Albans operation on processes and procedures that maximize the safety and reliability of the compounds we supply to medical device manufacturers,” said Mr. Paul Burke, business director for North America. Medalist elastomers are al ready f u l ly compl iant wi th regulations for medical uses and meet stringent standards for biocompatibility and purity.

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