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ISO 13485 certification - Standard NF EN ISO 13485

ISO 13485 is the reference standard for companies working in the medical devices sector. It is officially recognized in a large number of regulations.

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Presentation of the certification

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.

GMED delivers certificates in strict accordance with the international certification rules stipulated in Standard ISO 17021-1 (COFRAC Accreditation No. 4-0608).

List of sites and scopes available on www.cofrac.fr

Obtaining certification

Begin your application process to obtain the ISO 13485 certification by consulting the GMED certification rules and by requesting the information questionnaire, available with a simple click on the "Obtain a quote" button.

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