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Registration Documentation
(ISO 13485 / CMDCAS & MDSAP)

Request For Quote

Apply For Registration

Substantial Change QMS

General Conditions

Client Agreement


CE Marking

Transfer Application

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

IVD Substantial Change Application


IVD 3 Year Renewal Application


TYVEK Application Form


Vigilance Reporting


Post Market Surveillance Application


Equivalence Route


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)

Health Canada

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.

 

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