IRELAND FACILITY
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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