C&M Precision Tech Earns ISO 13485 Medical Device Certification
Appears in Print as: 'Company Earns ISO 13485 Certification for Medical Devices'
ISO 134585 is a globally recognized standard for medical device/component manufacturers to ensure compliance with internationally recognized best practices and safety protocols.
Edited by Angela Osborne
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C&M’s cleanroom meets Class 8 standards. Photo Credit: C&M Precision Tech
C&M Precision Tech, a manufacturer of precision-engineered and manufactured components and assemblies, is now ISO 13485:2016-certified. This qualification demonstrates C&M’s ability to provide medical device manufacturers with precision parts and assemblies by meeting standards that go beyond the ISO 9001 requirements and other quality standards that most manufacturers meet.
“Our ISO 13485 certification makes us a partner for complete medical machining and assembly solutions. It is the result of our team members’ hard work and dedication to the products’ end users,” says Dan Villemaire, C&M’s president. “This certification is one of the highest standards to meet and the most difficult to attain. As a company that serves customers in the defense and optics industries who have stringent quality requirements, this certification is a logical extension of our business that can help medical device manufacturers as the U.S looks to localize its supply chain.”
C&M says this certification is complemented by the company’s investments in its team member development, which includes training and promoting from within. It also has a clean room that meets Class 8 standards and offers state-of-the-art machinery, equipment and capabilities.
The company has also earned ISO 13485 certification (quality management for medical device manufacturing), AS 9100D/ISO 9001 certification (quality management for aerospace/defense products manufacturing), ISO 9001:2015 certification (general quality management) and is also compliant with NIST-800-171 standards for best practices in cybersecurity.
