BELGRADE, Mont.–(BUSINESS WIRE)–Feb 26, 2013–Bacterin International Holdings, Inc. (NYSE MKT: BONE), a leader in the development of revolutionary bone graft material and coatings for medical applications, today announced that it has achieved ISO 13485:2003 Certification. This certification is an internationally recognized management system standard developed by the International Organization for Standardization (ISO).
ISO 13485:2003 is a standard specific to medical device quality systems that supplements the ISO 9001 standard and provides a comprehensive quality management system for the design and manufacture of medical devices. Some of the specific requirements included in the ISO 13485:2003 standard include inspection and traceability, process documentation and validation, and verification of the effectiveness of preventative or corrective actions.
“The addition of the ISO 13485:2003 Certification strengthens Bacterin’s commitment to customer quality and service,” said Guy Cook, CEO of Bacterin International. “Our company has been a leader in the manufacturing and marketing of biologics. We look forward to leveraging this certification to further enhance and expand our product portfolio in regenerative medicine.” About Bacterin International Holdings Bacterin International Holdings, Inc. (NYSE MKT: BONE) develops, manufactures and markets biologics products to domestic and international markets. Bacterin’s proprietary methods optimize the growth factors in human allografts to create the ideal stem cell scaffold to promote bone, subchondral repair and dermal growth. These products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain, promotion of bone growth in foot and ankle surgery, promotion of cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries.
Bacterin’s Medical Device division develops, employs, and licenses bioactive coatings for various medical device applications. Bacterin’s strategic coating initiatives include coatings designed to inhibit biofilm formation and microbial contamination. For further information, please visit www.bacterin.com.