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.
We provide for the following Medical Devices Certification:
- ISO 13485 The internationally recognized Standard for a comprehensive management system for the design and manufacture of medical devices
- CMDCAS Canadian Medical Devices Conformity Assessment System, vital for selling into the Canadian market
- CE Marking Open up EU and EEA markets by obtaining a CE Mark for your Medical Device
The NSAI Medical Device department has just completed its latest Roadshow on the subject 'ISO 13485:2016 and the MDR - Major Changes and Impacts'.
Hosting a seminar in both Dublin and Galway NSAI Medical Device staff gave presentations on what's new in ISO 13485:2016 and the major changes and impacts the MDR will have on industry.
This latest NSAI presentation is now available to view here
Documents referenced during the ISO 13485:2016 presentation:
ISO 13485:2016 NSAI Technical Questionnaire (Word version is available from your NSAI auditor)
NSAI hosted two morning seminars on ISO 13485:2016 & the MDR in Dublin and Galway on the 18th & 20th May, The presentation given at these events is available below.
- Request a Quote
- Apply for Registration
- Substantial Change QMS
- Upload Documentation to NSAI
- General Conditions
- Client Agreement U.S
- Client Agremment Ireland
New website created by EU Commission to assist in communication on MDR/IVDR
The Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) is launching a communication campaign on the new Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR). They came into force on 25 May 2017 and a transitional period is foreseen until May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices.
- GOPA Com. has been chosen to undertake a series of targeted communication activities from 2018 onwards.
|Europe Offices||USA Office|
|NSAI European HQ
1 Swift Square
Dublin 9 D09 A0E4
T+ 353 1 807 3800
F+ 353 1 807 3878
|NSAI Galway Office
Ballybrit Business Park
Galway H91 NX52
T+ 353 1 807 3800
20 Trafalgar Square
Nashua, NH 03063
T+ 1 603 882 4412
F+ 1 603 882 1985
Medical Resource Links
- Medical Devices Directive (93/42/EEC)
- Active Implantable (90/385/EEC)
- In-VitroDiagnostic (98/79/EC)
- Health Canada
- European Commission (Medical Devices)
- IDA (Irish Development Agency)
- Enterprise Ireland
- Health Products Regulation Authority
- Medical Device Regulation 2017/ 745 EU
- In-vitro Diagnostic Regulation 2017/ 746 EU