Assured Confidence

Medical Devices

NSAI Medical Devices landing page showing an operating theater
NSAI offers a full range of services relating to Management System Standards and Certification Services for medical device manufacturers. We pride ourselves on offering the highest level of customer service and support available in the industry.

We provide for the following Medical Devices Certification:

  • ISO 13485 The internationally recognized Standard for a comprehensive management system for the design and manufacture of medical devices
  • CMDCAS Canadian Medical Devices Conformity Assessment System, vital for selling into the Canadian market
  • CE Marking Open up EU and EEA markets by obtaining a CE Mark for your Medical Device

14 March 2017

The NSAI Medical Device department has just completed its latest Roadshow on the subject  '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 what's new in ISO 13485:2016 and the major changes and impacts the MDR will have on industry.  

This latest NSAI presentation is now available to view here

Documents referenced during the ISO 13485:2016 presentation:

ISO 13485:2016 NSAI Transtion Policy

ISO 13485:2016 NSAI Technical Questionnaire (Word version is available from your NSAI auditor)

May 2016

NSAI hosted two morning seminars on ISO 13485:2016 & the MDR in Dublin and Galway on the 18th & 20th May,  The presentation given at these events is available below.

News on future events can be accessed on the NSAI Seminars web page as it becomes available.  You can also receive information on NSAI seminars direct by subscribing to
the NSAI E-zine.

Registration Documentation


Fed up with the lack of service from your current Notified Body? Interested in exploring your options but afraid that changing Notified Bodies will be more hassle than it's worth?

Fear not. NSAI has you covered with its SimpleSwitch program which takes the pain out of the process of changing Notified Bodies. We created the SimpleSwitch programe to allow companies easier access to our high quality and responsive service.

How does SimpleSwitch work? Find out more by reading this article.

Contact us today to find out how we can develop a customized programe for your organization to facilitate a SimpleSwitch from your current Notified Body to NSAI.

Contact Details

Europe USA
NSAI European Headquarters
1 Swift Square,
Northwood, Santry,
Dublin 9 Ireland

T+ 353 1 807 3800
F+ 353 1 807 3878
20 Trafalgar Square
Suite 603
Nashua, NH 03063, USA

T+ 1 603 882 4412
F+ 1 603 882 1985

Medical Resource Links

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