Analysis
Polymicro Technologies Earns Medical ISO 13485:2003 Certification, Further Enhancing Molex Presence in the Medical Industry
Molex Incorporated announces that its specialty fibre subsidiary, Polymicro Technologies, has achieved ISO 13485:2003 certification for its Phoenix, AZ location. The facility includes optical fibre drawing, precision laser machining, high-power laser assemblies and an environmentally controlled Class 7 low bio-burden room.
The “Achieving our ISO13485 certification has validated our processes and controls and has demonstrated our commitment to providing more complete fibre optic solutions to the medical industry,” states Jim Clarkin, general manager, Polymicro Technologies. “Having this in place will provide our customers with a higher degree of confidence in our already well-established medical products expertise and will complement other capabilities within Molex.”
Polymicro manufactures specialty optical fibres, capillary tubing, and completed fibre and capillary assemblies. The formalisation of the ISO 13485:2003 certification confirms its compliance of processes and procedures to meet the stringent demands of the medical industry. The certification was received through the BSI Group America Inc., which is the world’s largest management systems registrar and is a prominent registrar in the medical industry.
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