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Latest update : 28.11.2018
GMED: certification of company management systems
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Certification of Quality Management Systems

The reference standards used by companies in the medical device sector are:

  • NF EN ISO 13485
  • ISO 13485
  • ISO 9001

At a statutory level, compliance with harmonized European standard EN ISO 13485 guarantees conformity to all statutory requirements covering quality assurance systems (complete, production, product).

> Rules for GMED certification of quality management system

COFRAC accreditation
Certificates are issued in accordance with the international certification rules specified in standard ISO 17021 (COFRAC accreditation no. 4-0608).
Scope available on


For information on the GMED certification process, see the section Obtaining certification

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