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BioSyntech receives ISO 13485:2003 certification for its Quality Management System

09 Apr 2008 - BioSyntech, Inc. announced that it has achieved international certification under the stringent and globally recognized ISO 13485:2003 Medical Devices Quality Management System for its site located in Laval, Quebec. BioSyntech continues to maintain its ISO 9001:2000 certificate.
 
"By achieving ISO 13485:2003 requirements we have demonstrated that our medical device design, development and manufacturing processes meet objective quality standards. This important certification reflects our ongoing commitment to quality in the design and manufacturing of minimally-invasive solutions for the measurement and repair of damaged tissue," said Claude LeDuc, President and CEO of BioSyntech. "Within the next few months, we will seek global regulatory approval for Arthro BST(TM), our arthroscopic device used for the assessment of articular cartilage, with the submission of a CE mark application in Europe and a medical device license application in Canada."
 
The ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements.