FOR IMMEDIATE RELEASE
SpineFrontier Announces ISO 13485 Quality System Certification
BEVERLY, MA, September 18, 2009 - SpineFrontier™ is pleased to announce that it has achieved ISO 13485 registration and has received its certificate of registration from BSI Management Services of America. This is a significant milestone in SpineFrontier’s™ commercial strategy and a demonstration of our commitment to quality. President and CEO Kingsley R. Chin, M.D. thanked and recognized the contribution of the entire organization for their efforts in this achievement.
ISO 13485 is a globally recognized standard that defines quality system requirements for medical device design, development, production, and servicing. A certification to this standard is required for medical device manufacturers who seek to market their devices in the European Union, Canada, and other global markets.
“We are very excited to have achieved our registration and feel it is a testament to the level of value the SpineFrontier™ team places in developing high quality medical devices,” said John Sullivan, director of Quality Assurance and Regulatory Compliance. “Our quality system is the basis for future regulatory approvals in the global marketplace and this certification demonstrates that we have built a solid foundation.”
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SpineFrontier was founded by practicing spine surgeons with the belief that, as surgeons, we are best able to identify our own needs as well as those of our patients. Our team of surgeons, engineers and industry experts collaborate seamlessly on our innovations, helping us develop SpineFrontier into a company that is primarily driven to be a leader in innovation and cutting edge technology. SpineFrontier will assist us surgeons in solving the challenges we face daily, while treating our patients in the operating room.
SpineFrontier is constantly striving to design products that are rooted in the idea of providing the patient with a pain-free and comfortable lifestyle.
Contact:
Marwan M. Aylouche
Director, Product and Corporate Image
SpineFrontier
Phone: +1 978 279 9270
Fax: +1 978 232 3001
innovation@spinefrontier.com