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ISO 13485.

System Label recertified to ISO 13485.

Medical device, certified as ISO 13485, with display showing vital signs near a healthcare worker in a hospital setting.

ISO13485 is a stand-alone Quality Management System standard for medical devices. This certification has provided us with a planned and structured approach to develop and manage our quality Management system, there-by helping to adhere regulations, responsibilities and requirements of our medical device customers.

In January 2024, not only had we another successful ISO13485 audit by the NQA, our UKAS accredited certification body, but System Label celebrated a 10 year anniversary of first becoming ISO13485 certified.

Next, We look forward to our five-day triennial recertification audit that is scheduled for January 2025.

As a company and a team, we consider it important to maintain this compliance, as it once again certifies our quality system which helps us to offer good quality products and service to our Customers

Talk to us today to find out more about our quality and compliance processes. 

Contact us now: 
T: +353 (90) 663 0900  

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Close-up of an ISO 13485 certified medical monitor displaying vital signs in a hospital operating room, with blurry figures of medical staff in the background.

System Label certified to ISO 13485. 

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