BELGRADE, Mont., March 29 /PRNewswire/ -- 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.
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.
Certain matters discussed in this press release are forward-looking statements with regards to the Company’s future plans, objectives, and anticipated performance. These forward-looking statements can generally be identified as such because the context of the statement will include words, such as Bacterin International, Inc. “expects,” “should,” “believes,” “anticipates” or words of similar import. Bacterin International, Inc. believes the expectations reflected in any forward-looking statements are based on reasonable assumptions; the Company cannot give any assurance that the expectations will be attained. These forward-looking statements are only made as of the date of this press release; Bacterin International, Inc. undertakes no obligation to publicly update this information.
Bacterin International, Inc.