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Medical Device

Quality Management Systems

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Substantial Change QMS

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Medical Resource Links

Irish Medecines Board

IDA Irish Development Agency

Medical Device Directive: (93/42/EEC)

Active Implantable (90/385/EEC)

In-Vitro Diagnostic (98/79/EC)

Health Canada

Medical Device

NSAI offers a full range of services relating to Management System Standards and Certification Services for medical device manufacturers. We pride ourselves on offering the highest level of customer service and support available in the industry.

ISO 13485

ISO 13485 is the internationally recognized standard for a comprehensive management system for the design and manufacture of medical devices. It is often seen as the first step towards achieving compliance with European, Canadian and other regulatory requirements for medical device manufacturers.
> REQUEST QUOTE
> APPLY FOR REGISTRATION

CMDCAS: Canadian Medical Devices Conformity Assessment System–from NSAI

So you want to sell your medical devices in Canada? NSAI is ready to help your company gain access to the Canadian Marketplace. The first step in achieving this is to obtain ISO 13485:2003 certification under CMDCAS, which demonstrates that your company meets the Canadian QMS regulatory requirement for medical device licensing. Don’t have it? Good news, you’ve come to the right place.
> REQUEST QUOTE
> APPLY FOR REGISTRATION

CE MARKING

Want to sell your medical device in Europe? You’ll need a CE Mark.
A CE Mark is your declaration that the product complies with the Essential Requirements of the relevant European Legislation. By having a CE Mark, you will have immediate access to all EU and EEA Markets as well as any other international markets where CE Marking is accepted. Clients will also benefit from improved efficiency resulting from a streamlined quality management systems and gain consistent and effective control of key processes.
> APPLY FOR REGISTRATION

 

 

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