Medical Device Certification
NSAI Medical Device Certification Overview
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.
Read more about the NSAI Medical Device QMS and/or CE Certification Process
MDR / IVDR Information
NSAI is a designated Notified Body under both the Medical Device Regulation 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746.
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ISO 13485 Management System for Medical Devices
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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CE Marking for Medical Devices
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.
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Fees for Conformity Assessment Activities
Our pricelist for our MDR services can be found here. The pricelist provides transparency for our certification services, including discounts for SMEs.
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Impartiality Policy
NSAI places the utmost importance on the integrity and impartiality of its assessment activities and the trust it conveys to its clients, their customers and the public at large.
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Need a Quote?
Feel free to get in touch to start your certification journey. Make sure to click medical devices certification on the page below.
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