Medical Device
Quality Management Systems
Environment & Safety Management
IECQ Approvals
Standards Purchase
AS 9100 Rev. C Transition
IQNet
Live Link
3 Year Renewal
Substantial Change QMS
Customer Feedback
Registration Documentation
Request For Quote
Apply For Registration
Substantial Change QMS
General Conditions
Client Agreement
CE Marking
Apply for Registration: MDD or AIMD
Apply for Registration: IVDD
3 Year Renewal: MDD or AIMD
3 Year Renewal: IVDD
Change Documentation:
MDD or AIMD
Change Documentation: IVDD
Documentation Requirements
Demonstration of Compliance with
(2007/47/EC)
Medical Resource Links
Irish Medicines Board
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 - From CE Markings to CMDCAS and JPAL
NSAI is a leading Notified Body for medical device certification services. We have achieved this distinction by being the most responsive Notified Body in the market, giving our clients the level of service they deserve and require to get their products to market quicker. We offer a full range of Management System and Certification Standards for the medical device industry including:
ISO 13485
The global standard for comprehensive management system for the design and manufacture of medical devices. (read more)
CE MARKING
Want to sell your medical product in Europe? You’ll need a CE Marking from NSAI. (read more)
CMDCAS
The Canadian Medical Devices Conformity Assessment System is your ticket into the Canadian medical marketplace. (read more)
JPAL—Japanese Pharmaceutical Affairs Law
The Japanese Pharmaceutical Affairs Law governs the sale of medical devices in Japan. NSAI can help you obtain JPAL certification. (read more)
If you’re looking to get your products on sale in more markets across the globe, contact NSAI today. We know medical devices!