Medical Devices
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
- JPAL Japanese Pharmaceutical Affairs Law by the Ministry of Health Labour and Welfare.
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.
402 Amherst Street,
Nashua, New Hampshire,
NH 03063, USA
T+ 1 603 882 4412
F+ 1 603 882 1985
E info@nsaiinc.com |
Medical Resource Links
RH Rev. 1.0