Additional Value-Added Services

LNE/G-MED America provides a one-stop solution for your quality, training and testing needs. Our wide range of certification services and highly-trained auditors allow you to combine audits (such as for CE Marking and ISO 13485) to obtain cost-effective access to all of your desired markets.

In addition, our clients often take advantage of several other optional add-on services, such as:

Advantages

LNE/G-MED is recognized to assess Active Implantable Medical Devices and has significant experience certifying a wide range of devices for 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, ISO 14001) 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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