ISO 13485

Case Study: Volex Europe

Volex Europe, one of the leading global manufacturers and suppliers of interconnect/cable assembly ISO 13485_Volexsolutions including optical, high-speed copper and radio frequency products, has successfully achieved certification to the International Quality Management Standard ISO 13485, awarded by the British Standards Institute (BSI).

In less than 12 months: ISO 13485 Medical Devices Quality Management System for design and development.

Volex Europe provides products which are custom designed and manufactured to meet exacting customer requirements and tested in accordance with international standards. Volex Europe’s HQ is located in Castlebar, Co. Mayo, Ireland.

Almir Business medical devices consultancy practice successfully supported Volex Europe in establishing and implementing its ISO Quality Management System 13485 Medical Devices for design and development in less than twelve months.

ISO 13485 is the international quality management standard for designers and manufacturers of medical devices.

“Being certified allows us to further satisfy our key medical customers and create new opportunities”

Dr. John Hannigan, Director.

ISO 13485 specifies requirements for a quality management system where an organisation 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.

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If you would like to discuss how Almir Business Ltd can assist you with implementing a quality management system for health and safety, please Contact Us