TraumaCure Inc. – makers of the ground-breaking hemostatic agent, WoundStat™ – today announced that the company has received the prestigious international ISO 13485 certification for its quality system for design, development, production and sales of medical devices. The company received FDA clearance to sell WoundStat in August 2007
BETHESDA, Md. (Business Wire EON) June 24, 2008 -- With ISO 13485 certification, TraumaCure meets global quality design and manufacturing requirements. ISO certification is a base-line requirement in many key markets for approval to sell a medical device and therefore supports TraumaCure's plans to market WoundStat to nations around the world.
"As the only hemostatic agent proven to be 100% effective in four different studies, we are seeing worldwide demand for WoundStat," said Devinder Bawa, CEO of TraumaCure. "TraumaCure has put the processes and procedures in place to ensure the global availability of a consistent, safe, and effective product that is ready to save lives, anytime and anywhere it is needed."
ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. ISO has more than 16,500 International Standards in its current portfolio, ranging from standards for traditional activities, such as agriculture and construction, through mechanical engineering, manufacturing and distribution, to transport, medical devices, the environment, safety, information and communication technologies, and to standards for good practice and for services.
ISO 13485 is an internationally recognized quality standard for the design, development, production, and sales of medical devices. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
TraumaCure was certified after rigorous audits and extensive document reviews to ensure that TraumaCure's quality management system (QMS) is run in accordance with the globally recognized standard.
TraumaCure, based in Bethesda, Maryland, supplies the most effective, reliable treatments for life-threatening bleeding wounds. TraumaCure's hemostatic products help stabilize a wounded individual prior to receiving advanced medical treatment. The company's products are made in the U.S. and are proven to save lives and improve outcomes following traumatic injury. TraumaCure is committed to providing the most trustworthy and innovative hemostasis treatments for the military, emergency responders, and civilians.