ISO 13485
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?
When first to market is first in mind, choose the National Standards Authority of Ireland.
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
E medical.devices@nsai.ie |
NSAI Inc.
402 Amherst Street,
Nashua, New Hampshire,
NH 03063, USA
T+ 1 603 882 4412
F+ 1 603 882 1985
E info@nsaiinc.com |