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Dynacon Receives ISO 13485:2003 Certification and ISO 9001:2000 RecertificationTORONTO, ONTARIO. July 30 — Dynacon Inc. is proud to announce that it has been certified ISO 13485 compliant by an accredited body. The ISO 13485:2003 is an internationally recognized Medical Device Quality Management System (QMS) standard developed by the International Organization for Standardization (ISO). It specifies management requirements for medical device manufacturers. By meeting ISO 13485 guidelines, Dynacon demonstrates that its instruments’ design and development processes meet objective quality standards. “This certification adds a global stamp of approval for Dynacon’s quality management system,” says Dr. Reda Fayek, VP & GM. “It is also an objective confirmation of our rigorous internal quality control process. The addition of the ISO 13485:2003 certification bolsters our customers’ confidence in our continued focus on delivering quality products. The timing of this certification coincides with, and is essential for, a major push for the development of new instruments with compliance in mind.” In addition to the ISO 13485:2003, Dynacon has been recertified compliant with the ISO 9001:2000. It had initially achieved this certification in 2001. The ISO 9001:2000 standard specifies general requirements for quality management systems. With over 30 years’ experience in automation, Dynacon is the clear leader in analysis, design, simulation, fabrication, assembly and integration of pre-analytical microbiology automation. It offers a range of automated specimen processors that set the standard in pre-analytical microbiology sample processing. Built on the renowned inocuLAB platform, Dynacon’s family of products automatically inoculate, streak and bar-code microbiology specimens. Our inocuLABs are processing 13 million specimens every year in hospitals, research and clinical laboratories, and reference labs across the U.S., Canada, Sweden, The Netherlands, Denmark, Italy and Belgium. For further information, contact Steven Conly (e-mail: sdc@dynacon.ca). |
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