Newry firm achieves medtech accreditation in lockdown

  • Newry-based company, the Exact Group has achieved a new medical device compliance international accreditation during the lockdown period.

    The engineering firm has added ISO 13485 to its prolific aerospace and defence accreditations and awards, in order to engage with medical and pharma sectors more.

    ISO 13485 is a quality management system that demonstrates compliance to stringent medical device quality standards that consistently meet customer and other regulatory requirements.

    The Exact Group said this has helped the company to maintain its workforce and contribute to the health and wellbeing of the local community.

    RELATED: Newry engineering firm straight to SC21 aerospace silver

    Founder and manager director Stephen Cromie said: “I am delighted that we have achieved this medical accreditation, which clearly reinforces our commitment to quality and process excellence. I would like to thank our quality manager, Dermot Kelly and his team, for gaining this accreditation during these challenging times.

    “Dermot was only appointed as quality and continuous improvement manager in February this year, several weeks before the lockdown. To quickly understand our ethos and culture, accept this challenge and succeed in this short space of time is testament to him, his team and the Exact Group. Well done to all and thank you.

    “This medical ISO accreditation sets the company in good stead for working with the many companies in the pharma and medical sectors across the UK, Ireland and beyond.

    “In the meantime, we have designed and built our own hand sanitising foot pump operating unit, and that has been selling exceedingly well. We now hope to engage and help the wider medical industry with their engineering requirements going forward.”

    The Exact Group is most known for its marine, aerospace, and automotive work. This award adds to the business’ portfolio of industry recognised accreditations: SC21 Silver, ISO 9001 and AS9100.

    Source: Written from press release

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