(ISO 13485 / CMDCAS & MDSAP)
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Substantial Change QMS
New Class 1 Application
Class 1 Substantial Change Application
New Class IIa & IIb Non Implantable Application
Class IIa & IIb Non Implantable Substantial Change Application
New Class IIb Implantable, Class III, AIMD Application
Class IIb Implantable, Class III, AIMD Substantial Change Application
All MDD/AIMD 3 Year Renewal Application
New IVD Application
Medical Resource Links
Health Products Regulatory Authority
IDA Irish Development Agency
Medical Device Directive: (93/42/EEC)
Active Implantable (90/385/EEC)
In-Vitro Diagnostic (98/79/EC)
Europe and Canada… NSAI can unlock many markets for your medical devices with our international medical device certifications.
Easily Change Your Notified Body to NSAI with 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 program 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 program for your organization to facilitate a SimpleSwitch from your current Notified Body to NSAI.