Assured Confidence

ISO 13485 Management system for medical devices

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.

At NSAI, our customers come first. We’re committed, responsive and ready to serve the unique needs of the medical device industry. Our support team manages the various aspects of the certification process so that you don't have to, resulting in faster turn-around times, open communications and increased efficiency. In short, we deliver.

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 MDSAP and CE Marking.

Contact Details

Europe Offices   USA Office
NSAI European HQ
1 Swift Square
Northwood, Santry
Dublin 9 D09 A0E4

T+ 353 1 807 3800
F+ 353 1 807 3878 
NSAI Galway Office
Ballybrit Crescent
Ballybrit Business Park 
Galway H91 NX52

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

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

Return to NSAI Medical Devices main page
News & Events

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.


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.

NSAI Tweets
NSAI Media Channel