The ISO 13485:2003 certification will allow Molex to take projects from prototype through volume production in order to better serve the medical community.
“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.