Battelle Medical Device Solutions Earns ISO 13485:2003 Certification

March 13, 2007

 

Columbus, OH--Adding to its ISO 9001:2000 certification, Battelle Medical Device Solutions' quality management system has been certified to ISO 13485:2003 as part of its ongoing commitment to providing superior R&D services to the medical device industry.

"Achieving our ISO 13485:2003 certification is a very important milestone for our customers and for Battelle," said Karen Rosen, Quality Systems Manager for Battelle Medical Device Solutions. "It keeps our focus on maintaining product development processes that are compliant with the most stringent medical device industry quality standards."

 

Battelle Medical Device Solutions' ISO 13485:2003-certified quality system is designed to seamlessly dovetail with customers' existing quality processes, allowing it to be an extension of the client's development process.

 

Battelle Medical Device Solutions delivers a comprehensive set of Research, Development, and Product Support services to medical device, biotechnology, and pharmaceutical firms serving a wide range of therapeutic and diagnostic markets. Integrating design, engineering, and life science capabilities, Battelle Medical Device Solutions supports customers through the complete product life cycle by offering Applied Research, Device Development, Pre-Clinical & Clinical Research, and Sustaining Engineering services.

 

Battelle is the world's largest non-profit independent research and development organization, with 20,000 employees in more than 120 locations worldwide, including five national laboratories Battelle manages or co-manages for the U.S. Department of Energy. Headquartered in Columbus, Ohio, Battelle conducts $3.8 billion in R&D annually through contract research, laboratory management, and technology commercialization. Battelle provides innovative solutions to some of the world's most important problems including global climate change, sustainable energy technologies, high performance materials, next generation healthcare diagnostics and therapeutics, and advanced security solutions for people, infrastructure, and the nation. Battelle has a long history of developing successful commercial products in collaboration with its clients, ranging from products to fight diabetes, cancer, and heart disease to the development of the office copier machine (Xerox). As a non-profit charitable trust with an eye toward the future, Battelle actively supports and promotes science and math education.

 

For more information, contact Kevin Taylor at TaylorKM@Battelle.org or (614) 424-5215.