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.
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
FDA Quality System Regulation 21 CFR Part 820
FDA Registration number: 3005994106
Surmodics Ireland Certifications
ISO13485:2016
Accredited Quality System
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MDSAP Certificate
Accredited Quality System
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EC Certificate
Full Quality Assurance System
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