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 30 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.
LNE-GMED UK Ltd, is a subsidiary of GMED, located on the outskirts of London. LNE-GMED UK Board of Directors is made up of the President of GMED SAS, LNE exectives, GMED’s International Director and the General Manager / Head of Approved Body of LNE-GMED UK.
GMED Quality Policy [Excerpt]
“GMED is a key actor with multiple recognitions in the health industry.
GMED provides its customers with the best experts to enable them to access markets worldwide with innovative devices offering a high level of safety and performance for patients and users.
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”.
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
GMED 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 and Leadership’s Declarations on Conflict of Interest
For LNE-GMED UK subsidiary
General Manager & Head of Approved Body’s statement on certification Quality Policy [Excerpt]
“LNE-GMED UK Ltd. puts the best experts at its customers’ service to accompany them on their certification journey as they place regulated products on the market in the UK and internationally.
LNE-GMED UK LTD. undertakes work as a Certification Body for quality management systems and products relating to standards ISO 17021-1 and ISO 17065, and as an Approved Body for the UK regulation market. LNE-GMED UK LTD. provides certification within a voluntary or regulatory framework facilitating market access for various products.” […]
LNE-GMED UK takes being impartial, and being perceived to being impartial, very seriously. LNE-GMED UK recognises that impartially is essential to deliver confidence in its certification services. To this end, LNE-GMED UK strives to eliminate any threat to impartiality.
All LNE-GMED UK personnel must proactively seek out and addresses threats to impartiality, considering the following as a minimum:
- Self-interest: threats that arise from personnel or a body acting in their own interest. A concern related to certification, as a threat to impartiality, is financial self-interest;
- Self-review: threats that arise from personnel or a body reviewing the work done by themselves. E.g., auditing their own work is forbidden;
- Familiarity: threats that arise from personnel or a body being too familiar with, or trusting of, another person, instead of seeking audit evidence;
- Intimidation: threats that arise from personnel or a body being, or having the perception of being, coerced openly or secretively; such as a threat to be replaced, or reported to a supervisor.
LNE-GMED personnel are to be aware of impartiality threats and should act to eliminate them, to create an environment that nurtures trust and confidence in its services.
This policy, together with procedures, records and regular risk reviews form a significant part of our internal audit and regulator audit programme.
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 and its subsidiaries hold the authorizations, accreditations and international recognitions needed to support your certification projects in order to launch your medical devices on target markets.