CE Marking

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 also the MDR/IVDR Information.

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NSAI Inc. 20 Trafalgar Square
Suite 603, Nashua, NH 03063
(603) 882-4412
Toll free: 866-744-NSAI
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