Registration Documentation
(ISO 13485 / CMDCAS & MDSAP)

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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

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

Interested in CE Marking? You can open the doors to Canadian medical markets with the CMDCAS certification.

Let NSAI Help Your Company Achieve a CE Mark for Its Medical Device

If you want to sell your medical device in Europe you will need a CE Marking on the product to show it complies with European health, safety and environmental protection legislation. If you’re looking for a partner to help you achieve a CE Marking, look no further than NSAI.

At NSAI, we’re experts in helping companies achieve a CE marking for their products and stay compliant with Europe’s Medical Device Directive. We can start with a regulatory guidance before your CE Mark submission, we then provide conformity assessments, help file the correct paperwork, and provide ongoing surveillance to help your company maintain its conformity. This is why NSAI is able to offer the industry’s only time-to-market guarantee for CE marking services.

Interested in learning how NSAI can help your company achieve a CE Marking for its medical product by cutting through the regulatory red tape? Contact Us today or fill out our RFQ form and one of our experts will get back to you within 24 hours – guaranteed.

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