The timing of these certifications anticipates the manufacturing needs of extracorporeal affinity therapy products, currently under development within ExThera Medical, for the treatment of sepsis.
BERKELEY, Calif. (PRWEB) December 3, 2007
ISO 13485:2003 is an internationally recognized Medical Device Quality Management System (QMS) standard developed by the International Organization for Standardization (ISO). To be certified to the standard, companies must implement a Medical Device QMS ensuring steps have been taken to identify, manage and minimize the risks involved with the manufacturing and sale of medical devices. Certification to ISO 13485:2003 reinforces to customers through an independent third-party that PTG operates its Medical Device QMS in accordance with the standard.
ISO 9001:2000 is an internationally recognized quality management system standard also developed by ISO. To be certified to the standard, companies must implement a well-documented Quality Management System (QMS) that ensures consistency and improvement of working practices, including the products and services produced. Likewise, certification to ISO 9001:2000 reinforces to customers, through an independent third-party, that PTG operates a QMS in accordance with the standard.
"PTG has always been committed to excellent performance in both our internal manufacturing and OEM business," said Bob Ward, CEO. "The addition of the ISO 13485:2003 certification for our medical device activities demonstrates that our focus remains on quality, world-class performance and continuously monitoring our business operations to ensure that we deliver on the promises we make to our customers, employees and vendors."
In September 2007 Emergence LLC (http://www.emergence-llc.com), a life science incubator, was announced--a company with which PTG has strong contractual relations. The first company formed by Emergence is a 50/50 joint venture: ExThera Medical LLC, founded by Emergence and ExThera AB, a technology transfer partner of Karolinska Institute. The Emergence companies have substantial access to PTG's world-class staff and R&D/manufacturing facilities for polymer synthesis and processing, and for the regulatory approval and production of novel medical devices.
"The ISO 13485:2003 certification and ISO 9001:2000 recertification of PTG are expected to have a substantial and positive impact on Emergence and ExThera Medical," said George Pitarra, President of Emergence. "The timing of these certifications anticipates the manufacturing needs of extracorporeal affinity therapy products, currently under development within ExThera Medical, for the treatment of sepsis."
Polymer Technology Group (PTG) was co-founded in 1989 by Robert S. (Bob) Ward, who is a recognized pioneer in the field of biomaterials and the Company's CEO. PTG specializes in the research, development, design, scale-up, and manufacture of new polymers, medical devices, and components. PTG's commercial product portfolio also includes two of the world's most extensively tested biomaterials in clinical use today, BioSpan(R) segmented polyurethane and Bionate(R) polycarbonate urethane. In addition, PTG offers custom-fabricated components from its patented PurSil(R) silicone polyether urethane and CarboSil(R) silicone polycarbonate urethane. PTG's recently expanded operations to 53,000-square-feet comprise the equipment and expertise to support production-scale polymer synthesis through contract medical device manufacturing.