“We design, produce, and deliver medical devices, components, and services that meet customer and regulatory requirements through continuous improvement and an effective Quality Management System.”
ISO 13485:2016
Certified Quality Management System
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ISO 9001:2015
Certified Quality Management System
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"SurmodicsST is committed to operating in accordance with all applicable regulatory and customer requirements in order to provide customers with products and services of the highest quality while operating under an effective and compliant Quality Management System that drives continuous improvement through quality objectives.”
The SurmodicsST Quality Policy provides a framework for establishing the objectives, policies, and procedures that comprise our ISO 13485:2016 certified Quality Management System. Driven by top management, compliance with our quality systems, customer requirements, and applicable life science regulations is an organizational priority for all associates.
ISO 13485:2016
Certified Quality Management System
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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:
- ISO 13485:2016
- European Medical Device Regulation (EU) 2017/745
- 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 Management System Regulation 21 CFR Part 820
ISO 13485:2016
Certified Quality Management System
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MDSAP Certificate
Accredited Quality Management System
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EMS Certificates
Accredited Environmental Management System (EMS)
14.5485 CreaghMedical Ltd INAB Cert 2024 Download PDF
14.5485 Creagh Medical Ltd IQNet Cert 2024 Download PDF
Gender Pay Gap Report 2025
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Working accordingly to custom specific quality control protocols and GMP standards has been the core of what Surmodics Specialty Polymers does. We will adopt any QA/QC system described by our customers and our process for managing custom specific protocols are second to none.
In 2021 we decided to have our Quality Management System certified as your proof that Surmodics Specialty Polymers is capable of delivering as to our customers’ expectations and requirements. Either within the custom specific protocols or our own described QC systems.
ISO 13485:2016
Certified Quality Management System
Download PDF
ISO 9001:2015
Certified Quality Management System
Download PDF
