Access to World Markets

Medical device manufacturers trust the expertise of LNE/G-MED America to provide the necessary regulatory certifications, testing and training to access to European, Asian and other world markets.

As a Notified Body and Registrar, LNE/G-MED provides a full range of technical conformity services, from diagnostic audit and testing to certification and training.

One-Stop Convenience and Efficiency

With offices in Washington, DC, LNE/G-MED America offers the services a local team of technical experts, highly-skilled auditors and certification project managers who specialize in providing combined audits, such as for CE Marking with CMDCAS QMS (ISO 13485), to optimize audit time and cost.

The synergy between our American and European experts allow us to offer our clients an efficient solution to manage their domestic and international quality, regulatory and technical needs. We provide certification for a variety of world markets, including:

Advantages

LNE/G-MED America has the necessary expertise and experience working with manufacturers in obtaining CE marking, often in conjunction with ISO 13485, CMDCAS, third party FDA inspection and other certificates, to save the time and cost of multiple audits. You also benefit from:

• Local Washington, DC based office with qualified auditors throughout North America to increase convenience and minimize travel costs
• Simultaneous certification for CE Marking, Quality Management Systems (ISO 9001, ISO 13485) and other standards often performed by a single, highly-qualified auditor, to save you time and expense
• Widely recognized LNE/G-MED expertise as a European Notified Body (CE 0459), as an Accredited Certification Organization by France's accreditation body COFRAC, as a Registrar accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and recognized by Health Canada and as a Third Party Accredited Person by the U.S. FDA
• Added services, such as product testing (EMC, electrical, mechanical, CB Scheme), product certification, pre-assessment audits and fast-track or onsite review for CE Marking

Find Out More

LNE/G-MED America offers in-person, online and other customized training on a wide range of certification and quality topics. For details, check out our training schedule or request a customized program.

Contact LNE/G-MED America

• For proposals or other service questions: contact customer service
• Ask our experts to submit specific questions to our technical team