+1 866-744-NSAI Services Company Uploads Logos Feedback Contact Us Request a Quote Medical Device CE Marking Management System Registration and Certification Services NSAI is now designated under Medical Device Regulation 2017/745 CE mark is a legal requirement to place a medical device on the market anywhere within the European Union. In conjunction with ISO 13485 certification, this device specific evaluation supports a manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives that details the safety and performance requirements for medical devices. As a designated Notified Body under the Medical Device Directives, NSAI has the technical expertise and experience to provide the applicable CE marking services. See all applications and CE related forms See also the MDR/IVDR Information. Registration Documentation Request For Quote Apply For Registration Substantial Change QMS Medical Contract Schedule 1 Medical Contract Schedule 2 General Conditions Client Agreement Quick Links Standards Purchase Customer Feedback NSAI.ie Website IDA Irish Development Agency Contact Us NSAI Inc. 20 Trafalgar Square Suite 603, Nashua, NH 03063 (603) 882-4412 Toll free: 866-744-NSAI Employee Login FlowForma QPulse Login Concur Login Sharefile Copyright © 2021 NSAI Inc. Powered by Industrial Marketing

+1 866-744-NSAI Services Company Uploads Logos Feedback Contact Us Request a Quote Commitment to Impartiality NSAI’s management are committed to ensuring the impartiality, independence and objectivity of its certification services and actively manages any threat of actual or perceived conflicts of interest affecting NSAI’s certification and inspection services, its management, staff and auditors (including remuneration packages) and the activities of any associated functions. NSAI’s impartiality and objectivity is monitored by a dedicated committee providing oversight of NSAI activities and, in particular, the impartiality of its certification services and ensuring objectivity in its work. NSAI Medical Devices Commitment to Impartiality Any questions relating to impartiality should be addressed to the NSAI President, and will be reviewed by the Chairperson or the Certification Oversight Committee. Contact Us NSAI Inc. 20 Trafalgar Square Suite 603, Nashua, NH 03063 (603) 882-4412 Toll free: 866-744-NSAI Employee Login FlowForma QPulse Login Concur Login Sharefile Copyright © 2021 NSAI Inc. Powered by Industrial Marketing