Cygnus Manufacturing Company (CMC) Achieves Medical Device Manufacturing ISO 13485 Certification
SAXONBURG, PA. (August 26, 2010)-CMC, a contract manufacturer of products and components for the medical device, transportation, scientific instrumentation, energy, health & safety and aerospace markets has achieved ISO 13485:2003 certification. This certification 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 applicable to medical devices and related services.
"CMC is gratified that the company has achieved this important marketplace distinction. Additionally, we are very thankful and happy for our employees who have worked very hard to meet these stringent requirements," said Dennis S. Meteny, President & CEO.
"As we continue to target the medical device marketplace as a focal area for growth, this 13485 certification will open doors for us. Many of our current customers have been supportive of our efforts in this area and certainly offered encouragement and worked with us as we developed the quality system to meet their needs," added Meteny.
CMC received its ISO 13485 certification through the audit process conducted by Intertek, an international company providing quality management system certifications among many other services in the area of quality and safety for products, processes and systems.
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