Quick Links

Medical Device

Quality Management Systems

Environment & Safety Management

Standards Purchase

AS 9100 Certification Structure



3 Year Renewal

Substantial Change QMS
General Conditions

Client Agreement

Customer Feedback

Registration Documentation

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

Vigilance Reporting

Post Market Surveillance Application

Equivalence Route

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.

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.


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.



Copyright © 2015 • NSAI Inc. 20 Trafalgar Square-Suite 603, Nashua, NH 03063 • Toll free 866-744-NSAI • Sitemap