 Certification Services
Our LNE/G-MED America team includes technical staff specialized in product and regulatory certification along with production and project managers who facilitate convenient scheduling and address your concerns. To ensure responsive service, we provide clients with:
LNE/G-MED America employs auditors with multiple qualifications within their area of expertise, so we can often combine audits and services for different procedures (such as CE marking and ISO 13485), allowing you to save time and cost. Regulatory Certification to Meet Global RequirementsAs a globally-recognized notified and accredited body, LNE/G-MED can provide a one-stop solution for offering your products to a worldwide market. LNE/G-MED holds international accreditations from the Standards Council of Canada (SCC), the U.S. Food and Drug Administration (FDA) and Taiwan's Ministry of Health. We're also recognized as a conformity assessment body (CAB) by the United States, Australia and New Zealand. LNE’s partnerships allow us to provide our customers with access to the Japanese (JPAL) and Brazilian (Inmetro) markets. As an approved inspection body for over 20 European Directives, LNE plays a leading role in developing and applying European statutory certification (CE marking). Certification of Quality Management SystemsAn effective Quality Management System (QMS) is your best tool for reducing non-conformities and ensuring consistent production specifications. LNE/G-MED can provide ISO 9001 certification at the same time as statutory certification (CE marking, legal metrology), including standards, such as: ISO 9001, ISO 13485, ISO 14001, ISO 22000 and QSE (Quality, Safety and Environment) integrated management system. Product CertificationLNE issues its own certificates for packaging (LNE Emballage) and certifies products on behalf of French Standardization Association AFNOR (for the NF mark) and the French Association for Certification of Insulating Materials (ACERMI). We're also authorized to award certificates for the German Federal Ministry of Employment (GS mark), the European Standardization Committee CEN (Keymark), the British Retail Consortium and Institute of Packaging (BRC/IoP), the European Federation of Corrugated Board Manufacturers (FEFCO) and the European Solid Board Organization (ESBO). LNE provides certification for over 60 products ranging from toys to medical products. AdvantagesLNE/G-MED is able to provide a full range of voluntary and regulatory certifications to save you the time and cost of multiple audits. In addition, we offer:
Find Out MoreLNE/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
|
   |
- Progress Report - News
- MD Revisions Draft Amendments
- MD Classifications
- ISO 14971:2012
- MDD Revision: Actors, Roles and Responsabilities
- WEEE2 Directive
- Maintaining Compliance
- Revisions to the MDD
- ISO 13485 and FDA
- Controlling Outsourced Processes
- The Notified Body’s Role in Medical Device Certification
- EC Publishes E-Labeling Regulation
- IVD Updates
- Post-Market Phase
- IEC 60601 3rd Edition
- Tech File Evaluation
- Clinical Evaluation
- Recast of IVD Directive
- Own Brand Label Devices
- Software Engineering
- Med. Device Packaging
- Single Use Devices
- Usability Engineering
- FDA Use of ISO 13485
- Risk Management
- IVD Directive
- Switching Notified Body
- 60601 3rd Edition Status
- Regulatory News
- Ask Our Experts
- Free Guide: CE Marking
- Free Guide: IEC 60601 3rd Edition
- Free Guide: EMC Testing
- Free Guide: Brazil MD Approval
- Free Guide: Japan MD Approval
- Free Guide: IVD
- Technical FAQs
- Progress Report - News
LNE is committed to providing manufacturers with the technical solutions they need to ensure quality, speed innovation and offer products throughout the world. Our 770-person staff includes engineers, technicians, researchers and other experts in a variety of major sectors.
