ISO 13485 is the reference standard for companies working in the medical devices sector. It is officially recognized in a large number of regulations.
From a regulatory perspective, as a harmonized European standard, Standard NF EN ISO 13485 is to be presumed compliant with all pertinent quality management system requirements.
From a commercial standpoint, the compliance certification of a quality management system serves as an undeniable asset when: accessing international markets, setting up subcontracting relationships, and responding to calls for tender.
LNE/G-MED delivers certificates in strict accordance with the international certification rules stipulated in Standard ISO 17021-1 (COFRAC Accreditation No. 4-0038).
List of sites and scopes available on www.cofrac.fr
Begin your application process to obtain the ISO 13485 certification by consulting the G-MED certification rules and by requesting the information questionnaire, available with a simple click on the "Obtain a quote" button.