Medical Device
Quality Management Systems
Environment & Safety Management
IECQ Approvals
Standards Purchase
AS 9100 Certification Structure
IQNet
FlowForma
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
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.
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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.
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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.
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