ERJ staff report (RPN)
Stuttgart, Germany – Teknor Apex Co. has earned ISO-13485 certification for its factory in Oldbury, England, reports Rubber & Plastics News.
The facility produces Medalist medical thermoplastic elastomers.
ISO-13485 is an international standard for quality management in medical manufacturing. The UK facility has passed the final audit and is expected to achieve full certification by the end of quarter, according to Stef Hordijk, strategic market manager for the Thermoplastic Elastomer Division of Teknor Apex. A Medalist production facility in St. Albans, Vermont, USA, obtained ISO-13485 certification in 2010.