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.​
  • MDSAP The Medical Device Single Audit Program was developed by a group of medical device regulators to allow recognised third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485 and their respective regulatory requirements.  
  • CE Marking Open up EU and EEA markets by obtaining a CE Mark for your Medical Device

Registration Documentation


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 Document

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.

 

Contact Details

Europe Offices   USA Office
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 
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

Medical Resource Links

CM/JC Rev. 2

News & Events
13/04/2018

Minister Breen appoints James Kennedy as Chairperson to the Board of NSAI

The Minister of State for Trade, Employment, Business, EU Digital Single Market and Data Protection, Pat Breen T.D., today announced the appointment of Mr James Kennedy as Chairperson to the Board of the NSAI.

12/04/2018

Public Consultation on I.S. 820 Non-domestic Gas Installations

The National Standards Authority of Ireland wishes to announce the launch of a period of public enquiry  on I.S Non-Domestic Gas Installations.
 
 

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