Medical Device Manufacturing

Medical EquipmentNorth America is home to thousands of manufacturers of medical devices. While the U.S. Food & Drug Administration (FDA) regulates companies selling in the U.S., those wishing to sell internationally must seek certification services to meet the requirements of Canadian, European and other regulatory bodies.

To serve this need, while providing the benefits of a local team, LNE opened an office in Washington, DC in 2005. LNE/G-MED America offers certification, testing and training services in the medical sector. Executive Director Tarik Krim and his team offer a comprehensive range of solutions:

Advantages

LNE/G-MED America has the necessary expertise and experience to certify organizations under a wide range of regulatory certifications, including ISO, CE Marking and CMDCAS, to save you the time and cost of multiple audits. In addition, you 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

 

 

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