Surmodics, Inc.
Surmodics’ leadership in surface technologies dates to our development of the drug-delivery coating for the first drug-eluting stent. Since then, we’ve consistently pioneered breakthrough lubricious, hemocompatible, and drug-delivery COATINGS for the world’s leading medical device companies. But we’re more than a coatings company. Today, Surmodics provides differentiated whole-product solutions to device companies, with advanced balloon catheter design and production capabilities in the U.S. and IRELAND. We’re also a leading provider of chemical components for IN VITRO DIAGNOSTIC immunoassay tests and microarrays. We have a long history of bringing new products from concept to successful commercialization through close client COLLABORATION, frequently on accelerated timelines. We also serve as an enabling link between biotech and medical device companies to create unique drug/device combination products.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
This company also provides solutions for other industrial applications.
Please, visit the following links for more info:
About Us
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