Medical device manufacturers are subjected to many regulatory systems, international and national standards. This regulatory environment is constantly changing and influenced by many national and international forums and particularly the drive towards global harmonisation. NSAI is uniquely positioned to interpret the EU and global situation and guide on the emerging
medical device standards, requirements and regulations.
NSAI - Your Notified Body
As a Notified Body under the Active Implantable, In Vitro Diagnostic and Medical Devices Directives, NSAI provides particular expertise in the CE Marking of medical devices. Working with a world wide client base, NSAI has issued EC quality system certificates covering over 300 product families and in excess of 11,000 individual catalogue items.
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 certification:
Registration Documentation
SimpleSwitch
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
E 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
W www.nsaiinc.com |
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