(ISO 13485 / CMDCAS & MDSAP)
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Substantial Change QMS
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Class 1 Substantial Change Application
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Class IIa & IIb Non Implantable Substantial Change Application
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Class IIb Implantable, Class III, AIMD Substantial Change Application
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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)
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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