Ireland Facility

World-class design, development and manufacturing in Ballinasloe, Ireland.

Surmodics Ireland Building Photo

In 2015, we acquired Creagh Medical, an innovative developer and manufacturer of balloon catheters located in Ireland’s medical technology beltway. This world-class design, development and high-volume manufacturing facility has unique expertise in PTA balloon technology, producing the highest-pressure conventional balloons and most deliverable low-profile catheters on the market.

We attract some of the world’s most skilled and talented resources, with extensive medical device experience ranging from polymer science, mechanical design, and product design engineering.

Our commitment to quality
Our 12,000 square feet of cleanrooms are purpose-built and equipped to the highest standards, with all catheter technologies on site. These resources allow us to offer a total solutions approach, with capabilities ranging from product design and development, in-house extrusion, balloon forming, top assembly, packaging, and regulatory support throughout the product lifecycle. This vertical integration ensures the highest quality in our products throughout every phase of design, development and manufacturing. Our PTA products are approved in Europe, the United States, Japan, and other countries throughout the world.

Best-in-class medical device solutions
All critical aspects of balloon catheter manufacturing take place at our Ireland facility, ensuring consistent product quality, superior customer service and on-time delivery. In combination with our leadership in hydrophilic, drug-delivery and hemocompatible coatings, these capabilities make Surmodics the clear choice for medical device companies seeking next-generation balloon catheters designed and engineered to meet the most demanding clinical requirements.

ISO 13485:2012 Accredited Quality System
Creagh Medical is committed to provide quality medical devices that improve patient care, meet regulatory and customer requirements through an effective Quality Management System.

Established Compliance to:

  • ISO13485:2012
  • European Medical Device Directives 93/42/EEC
  • Canadian Medical Device Regulations MDR SOR/98-282
  • Japanese MHLW Ordinance No 169, 2004
  • FDA Quality System Regulation 21 CFR Part 820

FDA Registration number: 3005994106

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SURMODICS IRELAND CERTIFICATIONS

ISO 13485:2003
Accredited Quality System
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TUV Certificate
Accredited Quality System
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EC Certificate
Full Quality Assurance System
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