Medical Device Manufacturing

North 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.

• CE Marking in accordance with the European Directives on medical devices
• Quality Management System (ISO 13485 including CMDCAS for Canada)
• ISO Certifications on Sterilization, Environmental and other areas
• Third Party FDA Inspection by an Accredited Person (allowing time-saving combined audits)
• Access to Asian Markets
• Training through live presentations, online events and customized educational programs

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

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