IRELAND FACILITY

Surmodics world-class balloon catheter design, development, and manufacturing facility, located in Ireland’s medical technology beltway, includes 8000 sq. feet of custom-built cleanrooms. We provide lean manufacturing with capability for high-volume global supply.

All critical aspects of balloon catheter manufacturing take place at our Ireland facility, ensuring consistent product quality, superior customer service, and on-time delivery. Our capabilities range from product design and development, in-house extrusion, balloon forming, top assembly, packaging, and regulatory support throughout the product lifecycle.

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ISO13485:2016 Accredited Quality System

Surmodics Ireland 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:

  • ISO13485:2016

  • European Medical Device Directives 93/42/EEC

  • Canadian Medical Device Regulations MDR SOR/98-282

  • Japanese MHLW Ordinance No 169, 2004 as amended by MHLW MO No 60 (2021), PMD Act

  • FDA Quality System Regulation 21 CFR Part 820

FDA Registration number: 3005994106

Surmodics Ireland Certifications

ISO13485:2016
Accredited Quality System

MDSAP Certificate
Accredited Quality System

EMS Certificates
Accredited Environmental Management System (EMS)

14.5485 Creagh Medical Ltd INAB Cert 2024 Download PDF

14.5485 Creagh Medical Ltd IQNet Cert 2024 Download PDF