GMED SAS is a simplified joint-stock company with its parent company, the French National Metrology and Testing Laboratory (LNE), as its sole shareholder. GMED has been a subsidiary of LNE since August 1, 2018. With this new flexible organizational structure, GMED is able to grow while offering its customers the same high-standards and quality services that it has offered over the last 25 years in the certification market. By doing so, it is helping to make the health care and medical devices industry more competitive.
The primary mission of the GMED SAS Supervisory Board is to approve the company’s strategic direction and oversee its implementation. It is governed by French law and made up of 3 to 8 individuals appointed by the sole shareholder, the Managing Director of LNE and members of management at LNE.
GMED North America, Inc. is a subsidiary of GMED, located in the Washington, D.C. metro area. The GMED North America Board of Directors is made up of the President of GMED SAS, LNE as a guest member, and the President and CEO of GMED North America.
Our Quality Policy [Excerpt]
“GMED is a key actor with multiple recognitions in the health industry.
GMED put the best experts at its customers’ service to accompany them in their certification project in view of putting the medical devices on the market in France and internationally.
The success and the high level of performance of GMED is based on excellence, the know-how and the implication of its teams trained at the highest level on the currently applicable evaluation and certification methods.
GMED conducts missions as a certification body for quality management systems in the sense of the standard ISO 17021-1 and as a notified body in the sense of European regulation. GMED provides certification within a voluntary or regulatory framework facilitating market access to various medical devices.
GMED as management system certification body and notified body commits to meet customer’s expectations and applicable regulatory and normative requirements.
In particular, GMED commits to:
- Define and implement non-discriminatory management rules,
- Act with impartiality towards customers,
- Set necessary means to ensure the respect of confidentiality rules applicable to the staff involved,
- Set measures to avoid conflicts of interest and ensure their effectiveness,
- Provide necessary training to meet skills criteria for staff involved in certification. Likewise, GMED commits to provide training to the staff involved in evaluation processes and also make sure that laboratories performing compliance tests comply with ISO 17025 standard,
- Ensure or contribute to the promotion and development of the different certification systems,
- Ensure or contribute to the defense of corresponding collective certification marks,
- Define and implement procedures to respond to complaints, appeals and disputes by taking the fairest decisions according to the concerned case.
GMED commits towards competent authorities and other certification bodies to comply with the requirements defined by regulatory texts such as European directives and regulations, and satisfy the criteria defined for its designation or recognition. Furthermore, GMED commits to respect the ethical principles defined among notified bodies. As such, GMED signed the “Code of Conduct for Notified Bodies” within the framework of medical devices directives 90/385/EEC and 93/42/EC.
To carry out its missions and fulfill these commitments, GMED has an internal organization allowing us to pilot the certification activities transparently and independently from other activities.
GMED is fully responsible for decisions related to the granting, maintenance, extension, suspension, or withdrawal of certification.
This organization gives confidence in the quality of certification services provided and helps reach quality objectives.
Its quality objectives are identified as follows:
- Meet regulatory and normative requirements in terms of product certification, service, and system certification,
- Meet clients’ expectations by fulfilling our obligations and developing our ability to answer market needs,
- Contribute to GMED efficiency. […]”
President’s Statement on Certification Quality Policy
Our Impartiality Policy
The cornerstones of GMED’s commitment to ensuring trust are thorough certification and assessment processes and objective decisions. GMED’s values and the provisions established to prevent impartiality risks play a key role in this process.
As part of its quality policy, through its President, GMED is committed to ensuring impartiality and collecting, processing and verifying all information, so that GMED’s services foster the highest level of trust.
President’s Declaration on Conflict of Interest
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.
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.