23/02/2011

www.gupta-verlag.de/thermoplastic-elastomers

Medalist plant receives ISO 13485 certification

"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 Paul Burke, business director for North America.Developed for device manufacturers, ISO- 13485 is not an essential standard for a compounder, noted senior medical market manager Nick Sandland. "Medalist elastomers are already fully compliant with regulations for medical uses and meet stringent standards for biocompatibility and purity,” Sandland said. "Teknor Apex undertook procedures for achieving ISO-13485 certification in order to provide our customers with an extra dimension of quality assurance and to demonstrate our commitment to the Medalist brand.”

www.gupta-verlag.de/thermoplastic-elastomers