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Accreditation

Established in 1994, GMED is fully owned by LNE (e.1901), a State owned Industrial and Commercial Establishment (EPIC), and has been operating since August 1st, 2019 as a simplified joint stock company (SAS) within the LNE group.

With offices in Europe and a dedicated US Operation created in 2005 - GMED North America (MD) - GMED offers the convenience and efficiency of a local team of medical device experts and specialists to accompany you and your certification project.

Information on LNE’s accreditation with COFRAC can be found on here.

> Accreditation with COFRAC

GMED is accredited under the NF EN IEC/ISO 17021-1:2015 standard by COFRAC (Certificate № 4-0608), the French Accreditation Committee, to carry out Quality Management System Certification activities according to ISO 9001:2015 and ISO 13485:2016 in medical devices and health field.

Download GMED’s COFRAC Accreditation Certificate.

> Notified Body - Medical Devices and CE Marking

GMED is a leading Certification Organization and a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives:
• Directive 90/385/EEC - Active Implantable Medical Devices (AIMD)
• Directive 98/79/EC - In vitro diagnostic medical devices (IVDD)
• Directive 93/42/EEC - Medical devices (MDD)

Information on GMED’s notification scope can be found here.

> MDSAP Auditing Organization (AO)

“The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. “

Source:https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

GMED is an Auditing Organization Recognized by the MDSAP Regulatory Authority Council and has been performing MDSAP audits as early as April 2015. Learn more about the Medical Device Single Audit Program (MDSAP) and choose GMED to answer your MDSAP certification needs.

Contact us today!

> Mutual Recognition Agreements with Australia and New Zealand

GMED is a recognized Conformity Assessment Body (CAB) under signed mutual recognition agreements between the European Union (EU), Australia and New Zealand.

> Mutual Recognition Agreement with Taiwan

Under Taiwan’s medical device regulations, medical device manufacturers are required to set up an organization that complies with the Good Manufacturing Practice (GMP) code. Certification to the ISO 13485 standard is recognized as equivalent to GMP. Taiwan’s Department of Health has set up a Technical Cooperation Program (TCP Program) under which foreign certification bodies are recognized for certification of European production sites. GMED is accredited since November 2004 by the Ministry of Health and Welfare (Taiwan) to carry out audits according to ISO 13485:2016.

In order for a local distributor to obtain a license, GMED supplies the manufacturer with:

  • A cover letter confirming the validity of the last audit report;
  • The certificate confirming that the Quality Management System (QMS) complies with the ISO 13485 standard;
  • The audit report (in English);

Note: The manufacturer must also obtain a Certificate of Free Sale (CFS) from the Competent Authority (CA).

If you would like to learn more about it, contact us today!

> GMED's Certification Rules for the Quality Management System (QMS)

The purpose of the present rules is to specify the terms and conditions for the certification of Quality Systems by GMED, the notified body, in accordance with the national and international regulations applicable to quality assurance for the design, production, distribution or provision of a service in the field of health and medical devices.

Download GMED’s Rules of Certification for the Quality Management Systems

 

 

 

 

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clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors, and Resources Qualification Manager For Medical Devices Certification