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Registration Documentation
(ISO 13485 / CMDCAS)

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

At NSAI, we know medical devices! If you’re interested in ISO 13485, you may also be interested in CMDCAS or CE Marking.

ISO 13485 Medical Device Manufacturing System Quality Management Certification from NSAI

ISO 13485 is a necessary certification for medical device manufacturers. It proves that you have a quality manufacturing process and the management standards in place to maintain high quality. ISO 13485 certification is the first step towards achieving compliance with European, Canadian and other regulatory requirements for medical device manufacturers.

Simply put, if you want to sell your product globally, you need to be ISO 13485 certified.

NSAI is a Notified Body that specializes in medical device certifications. We’re committed, responsive and ready to help your company achieve ISO 13485 certification. Our support team manages the various aspects of the certification process so that you don't have to, resulting in faster turn-around times, open communications, increased efficiency, and your product in the market sooner. In short, we deliver.

Interested in learning how NSAI can help your company become ISO 13485 certified?
Contact us today or fill out our RFQ form. One of our experts will get back to you within 24 hours – guaranteed.

When time is of the essence, choose the National Standards Authority of Ireland.

 

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