Recognition and Accreditation

GMED holds the authorizations, accreditations and international recognitions needed to support your certification projects in order to launch your medical devices on target markets.

1.Quality Management System Certification

GMED is accredited under NF EN ISO/IEC 17021-1:2015 for quality management system certification under NF EN ISO 9001:2015 / ISO 9001:2015 and ISO 13485:2016 / NF EN ISO 13485:2016 for health care and medical devices.

Logo COFRAC Certification

Certificates are issued in accordance with international certification rules set out in ISO 17021 (French accreditation committee COFRAC accreditation no. 4-0608).

List of accredited sites and scopes available at www.cofrac.fr

 

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2.CE Marking

GMED is notified by the French National Agency for Medicines and Health Products Safety (ANSM) and, as a notified body (ID no. 0459), performs all conformity assessment procedures covered by:

  • European Regulation (EU) 2017/745 on medical devices
  • the following European Directives:
    – 90/385/EEC as amended by Directive 2007/47/EC- Active Implantable Medical Devices (AIMD)
    – 93/42/EEC as amended by Directive 2007/47/EC- Medical Devices (MD)
    – 98/79/EC – In Vitro Diagnostic Medical Devices (IVDMD)

The scope of GMED’s notification is available on the European Commission website NANDO (New Approach Notified and Designated Organisations).

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3.MDSAP Program

GMED is recognized as an Auditing Organization (AO) by the MDSAP Regulatory Authority Council (the international MDSAP governing body) and has been performing MDSAP audits since April 2015. 

MDSAP is a program designed to allow medical device manufacturers to have their quality management system (QMS) assessed with regard to the regulations of five countries: Canada, Brazil, Australia, Japan, and the United States.

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4.Mutual Recognition Agreements (MRAs)

The mutual recognition agreements signed between the European Union and  Australia and New Zealand, implemented in 1998, allow manufacturers to obtain certificates after GMED completes its service as a designated body under these agreements.

The agreements cover medical devices under Directives 90/385/EEC and 93/42/EEC, with the exclusion of radioactive products, in vitro diagnostic devices, devices utilizing tissue of animal origin, devices incorporating medicinal substances, and devices with special risks.

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5.Technical Cooperation Program

GMED was recognized by the Ministry of Health and Welfare (Taiwan) in November 2004 to conduct ISO 13485:2016 audits.

ISO 13485 is recognized as the equivalent of the Good Manufacturing Practice (GMP) standards. Taiwan’s Ministry of Health has set up a Technical Cooperation Program recognizing foreign organizations that are qualified to certify companies in the European Union, Liechtenstein and Switzerland.

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6.Partnerships

GMED’s certificates are recognized by some certification bodies in Ukraine.

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Choose GMED

Our teams of experts, dedicated to the health care and medical devices industry, and our proven practices make GMED among the leading companies at an international level.

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