14 March 2017

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.

Documents referenced during this presentation:

ISO 13485:2016 Transtion Policy

ISO 13485:2016 Technical Questionnaire (MS Word copies are available from your NSAI auditor)

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.

Interested in learning how NSAI can help your company become ISO 13485 certified?

Contact us today or fill out our Request for Quote form.

When first to market is first in mind, choose the National Standards Authority of Ireland.
Interested in ISO 13485? You may also be interested in CMDCAS and CE Marking.

Contact Details

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

T+ 353 1 807 3800
F+ 353 1 807 3878
E medical.devices@nsai.ie 
NSAI Galway Office
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Ballybrit Business Park 
Galway H91 NX52

T+ 353 1 807 3800

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Suite 603
Nashua, NH 03063

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