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Toul Meditech AB achieves certification according to ISO 13485:2003
Certified ISO 13485

The Swedish innovation company Toul Meditech AB received certification approval from the notified body SEMKO Certification AB, part of the Intertek group, on the 30th of October for its Quality Management System in accordance with ISO 13485:2003.

The Quality Management System covers design, production and marketing of laminar airflow units including sterile accessories in order to remove bacteria carrying particles and to reduce the infection risk in the operation environment.

"Our Quality Management System is a fundamental part of our business and the ISO certification proves that our company can meet the very high standards that are essential for medical device manufacturers" says Tomas Hansson, Design Manager at Toul Meditech AB. "The certificate and our focus on quality and safety matters is an very important element for our business expansion and a very good foundation to continue to offer solutions to health care providers that requires effective tools for fighting air borne contamination, in order to reduce the risk of infection at surgical procedures”.

ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. ISO is a global network that is active in several business areas. ISO 13485:2003 is a quality management system standard that is especially adapted to meet the requirements for medical device manufacturers. Additional information is available at www.iso.org.

Toul Meditech AB has since 2003 successfully marketed its patented and medically classified mobile systems for laminar airflow on the Scandinavian market. The airflow is ultraclean and distributed horizontally over the wound area and/or sterile instruments. The airflow constitutes a barrier which reduces the occurrence of bacteria carrying particles and by that; the risk for post-op infections is reduced.

Toul Meditech AB head office is located in Sweden, with representation in several European countries.

Contact
Tomas Hansson, Development manager and founder of Toul Meditech AB + 46 0709-503081, tomas.hansson@toulmeditech.com