Volex Europe Achieves ISO 13485 Certification for Design

Volex Europe, one of the leading global manufacturers and suppliers of interconnect/cable assembly solutions 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). 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 13485 Medical Devices Quality Management System in less than twelve months for design and development.

Commenting on the award, Engineering Director and Quality Management Representative, Dr. John Hannigan, said “Medical device companies look for partners who are accountable to the same regulatory standards to which they are held. ISO 13485 certification is a tribute to our continued focus on exceeding customer expectations, and validates our commitment to our high quality standards and the needs of our customers. Being certified allows us to further satisfy our key medical customers and create new opportunities”.

[intlink type=”p” slug=”medical-devices-iso-13485″ text=”ISO13485″] is the international quality management standard for designers and manufacturers of medical devices. 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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