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Moll Industries Ireland announce ISO13485 Medical Device Certification

Monday, 25 July 2011

In addition to celebrating the completion of its first year since their Management Buyout, Moll Industries Ireland Ltd. today announced successful certification to the ISO 13485: 2003 Quality Management Standard for Medical Devices.

The ISO 13485:2003 guideline requires that an organization demonstrate its ability to provide medical devices and related services that consistently meet both customer and regulatory requirements. This stringent certification represents more than a twelve-month commitment on the part of the Moll Industries Ireland team and provides medical customers with the assurance that Moll Ireland’s products will provide the quality they demand.

"It has been an exciting year for Moll Ireland" said Helen Masterson, Managing Director, This was a monumental team effort and serves to highlight our ongoing commitment to both product quality and to attaining the industry certifications that our customers require."

Recognised around the world, the ISO13485:2003 is based on eight quality management principles: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact based decision-making and mutually beneficial supplier relationships.

“ISO 13485:2003 certification brings world class status to Moll Industries Ireland, and it provides confidence to our customers through our dedication to quality compliance” said Michael Masterson, Business Development Director at Moll. “This certification will allow us to expand our offering to our existing customers and opens the door for us to enter new markets”

About Moll Industries Ireland Ltd.

Moll Industries Ireland Ltd. ( is an Expert Medical Moulding Partner located in Donegal Town that services a range of Medical Device and Pharmaceutical companies throughout Europe. Its facilities include both Class 10k and 100k clean rooms; state of the art injection moulding machines to 300 tonnes; custom-built assembly equipment and the logistics.
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