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Cogent Technology operates and complies with internationally recognised quality systems, standards and legislation, manufacturing medical device products in a transparent and auditable environment. All medical devices manufactured by Cogent have complete traceability and have been designed, developed and manufactured using standards specified by ISO 13485:2003. Cogent Technology is an FDA registered manufacturing site.
Engineers by nature, when Cogent Technology set about meeting the requirements of ISO13485 we worked closely with our business systems providers to build compliance into our workflow. So our MRPii system doesn’t just generate works order demand for a device, it defines the routing, performs shop floor data collection to build a medical device history record, verifying appropriate use of components, the suitability of operators to carry out the tasks and collecting test results. All of this is