BELGRADE, MONTANA, MARCH 29, 2010 --- Bacterin International, Inc. (Bacterin), a medical device and biologics manufacturing company, is pleased to announce it has received certification from the International Organization for Standardization (ISO) for fulfilling the requirements of ISO 13485:2003. To accomplish this goal, Bacterin worked with BSI, a leading provider of independent third-party certification of quality management systems.
"This is a significant milestone for Bacterin and we are proud of this accomplishment," said Darrel Holmes, Bacterin's Vice President Medical Devices. Mr. Holmes continued, "The ISO 13485:2003 certification assures our customers and partners of our commitment to quality, and in the quality of our innovative products and processes. Additionally, we are looking forward to the new markets and business opportunities that ISO 13485:2003 certification offers for our products in the global marketplace."
ISO 13485:2003 specifies requirements for a quality management system. To obtain ISO 13485:2003 certification, an organization must demonstrate its ability to provide medical devices that consistently meet applicable customer and regulatory requirements. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
About Bacterin International, Inc.
Bacterin International, Inc. designs, tests, and develops bioactive coatings for medical device applications. Bacterin also develops innovative biologic products for transplantation. The company was founded in 1997 based on expertise gained from the Center for Biofilm Engineering at Montana State University. Since its inception, Bacterin has been an innovative and dynamic company in the field of biomaterials research, testing, development, and commercialization. Bacterin is continuing to expand its IP base and has successfully leveraged its technical expertise and knowledge of biofilms into multiple product areas. Bacterin is well positioned for future growth through established partnerships with major medical device manufacturers and ongoing internal product development of innovative tissue constructs and bioactive coated devices. Bacterin's proprietary coated medical device, Elutia(R), is the first antimicrobial-coated wound drain on the market and is available for various applications including: orthopedic, plastic and reconstructive, neurological, gynecological, head and neck, thoracic/cardiovascular, and general surgery. Bacterin's proprietary biologic scaffolds include OsteoSponge(R), OsteoWrap(R), OsteoSelect(R), OsteoLock(R), and BacFast(R).
For more information regarding Bacterin, or this press release, please visit www.bacterin.com.
source: web of industrysourcing
