Interested in Learning How NSAI Can Help Your Company Become ISO 13485 Certified?


ISO 13485 is the internationally recognized standard for a comprehensive management system for the design and manufacture of medical devices. It is often seen as the first step towards achieving compliance with European, Canadian and other regulatory requirements for medical device manufacturers.

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Recent Roadshow Presentations

The NSAI Medical Device department has just completed its latest Roadshow on 'ISO 13485:2016 and the MDR - Major Changes and Impacts'. ​Hosting a seminar in both Dublin and Galway NSAI Medical Device staff gave presentations on the transition to, and what's new in, ISO 13485:2016 and the major changes and impacts on industry of the MDR.

This latest NSAI presentation is now available to view: ISO 13485:2016 & MDR
Documents referenced during this presentation:

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About CE Marking

You may also be interested in CE Marking, which is your declaration that the product complies with the Essential Requirements of the relevant European Legislation. By having a CE Mark, you will have immediate access to all EU and EEA Markets as well as any other international markets where CE Marking is accepted.

Contact Us

Europe Offices

NSAI European HQ
1 Swift Square
Northwood, Santry
Dublin 9 D09 A0E4
Ireland

T+ 353 1 807 3800
F+ 353 1 807 3878
E medical.devices@nsai.ie 

NSAI Galway Office
Ballybrit Crescent
Ballybrit Business Park 
Galway H91 NX52
Ireland
T+ 353 1 807 3800
medical.devices@nsai.ie 

USA Office

NSAI Inc.
20 Trafalgar Square
Suite 603
Nashua, NH 03063
USA


T+ 1 603 882 4412
F+ 1 603 882 1985
E info@nsaiinc.com