Berkeley, California - Biomaterials business Polymer Technology Group, which specialises in polyurethane-based products, has announced that it has earned ISO 13485:2003 certification and ISO 9001:2000 recertification from BSI Management Systems, a management systems certification and notification body.
ISO 13485:2003 is an internationally recognised Medical Device Quality Management System and ISO 9001:2000 is an internationally recognised Quality Management System standard -- both are developed by ISO (the International Organisation for Standardisation).
Robert Ward, ceo of PTG, said in a 3 Dec statement that "This strengthens PTG's position as the leading vertically integrated company in the biomaterials sector of the medtech industry."
PTG's commercial offerings include BioSpan segmented polyurethane and Bionate polycarbonate urethane; it describes these as, "two of the world's most extensively tested biomaterials in clinical use today."
The company can also custom-fabricate components from its patented PurSil silicone polyether urethane and CarboSil silicone polycarbonate urethane. (ss)