Quality Managment Award is boost for Galway company

A Galway company has recently become the first Irish Certification Body to be accredited to provide certification and registration to the Medical Device Quality Management System Standards (ISO 13485).

Based in Clarinbridge, Business Quality Assurance International is the only Irish Certification Body to be accredited by the Irish National Accreditation Board.

This achievement enables Irish and Irish based organisations to source international certification locally where ease of access and added benefits of quick response, information and support are readily available.

ISO 13485 is the model standard for the medical industry and addresses quality system requirements in global markets including Europe, USA, Australia, Japan and Canada.

“Certifications build trust – a crucial factor when it comes to medical devices“, says Declan O’ Connor, Chief Executive and Director of Certification of BQAI.

“Through the INAB accreditation process BQAI have demonstrated the highest levels of professional competence in the delivery of Medical Devices’ certification services,” continued Declan O’Connor.

ISO 13485 Certification is critically important to medical device manufacturers and their suppliers in facilitating access to global markets.  Implementation of this standard reduces operational costs and significantly improves process efficiency.

“As Galway is recognised as the European Hub for Medical Device manufacturing, BQAI is ideally placed to service the industry needs of multinationals and SMEs from our Galway Headquarters,” he added.