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CB Scheme Certification

cb scheme testing multi countriesThe CB Scheme is an international agreement between Certification Bodies on mutual recognition of test results. This enables manufactures of electro-medical devices to streamline testing requirements for the 49 member countries of the program (including Argentina, Australia, Brazil, Canada, Korea, United-States, India, Japan, Russia and others).

The IECEE (International Electro technical Committee for Conformity Testing to Standards), which created the CB Scheme for electrical equipment, recognizes LNE/G-MED as an organization of certification (National Certification Body) and Certification Body Testing Laboratory (CBTL) under the international agreements of the CB Scheme (AHJ) for medical devices.

LNE/GMED performed tests are based on IEC standards including the national deviations for different countries. The main areas of LNE/GMED recognitions are:

  • IEC 60601-1 ed 2: General safety rules
  • IEC 60601-1-1: Safety of electrical systems
  • IEC 60601-1-2: Electromagnetic compatibility
  • IEC 60601-1-3: Protection against radiation from X-ray equipment
  • IEC 60601-2-7: Safety generators radiological diagnostic X-ray groups
  • IEC 60601-2-32: Safety-related equipment X-ray
  • IEC 60601-2-18: Safety of endoscopic equipment
  • IEC 60601-2-38: Safety of electric beds
  • IEC 60601-2-43: Safety of response procedures for X-ray equipment

Advantages

LNE has experience working with manufacturers to test a wide range of devices, providing an economical and reliable solution. In addition, we offer:

  • Access to Top Testing Facility

    With highly advanced testing equipment and over 60,000 square yards of laboratory space, LNE can address a wide range of standardized tests or customize a test to characterize your product.
  • Post-Testing Insight from Technical Experts

    Our multidisciplinary teams possess deep knowledge on various European, international and other regulatory standards. Throughout the entire testing process, our team is available for technical meetings to provide insight into any discovered non-conformities.
  • Local Point of Contact

    With offices worldwide, you get the conveniency of a local based team, who will work with you closely to define program details and ensure your timeframe is met.

Combo Training ISO13485 MDSAP

Questions?

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

   1-301-495-0477

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clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

Training LNE G MED

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

2 days course 

Click here to Register