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Electromagnetic Compatibility (EMC)

Notified Body Testing Electro medical equipmentMedical devices are expected to perform at a certain level in any electromagnetic environment without causing interference to other equipment.

LNE can test your devices to ensure conformity to harmonized European or other EMC standards and for voluntary certification.

Our technical team provides assessment of finished products, components and prototypes of medical devices. We also analyze technical files to define tests programs and performance of tests.

 

Core Capabilities

Testing lectromagnetic compatibilityWith its EMC chamber immunity and benches, LNE performs EMC tests according to EN 61000-4-3, with a capability to generate electromagnetic fields from 26 MHz to 3 GHz. Its test cage allows performing tests from 3 to 5 meters away from antenna.
LNE tests all electrical and electronic equipment (plug-in or battery operated), which is liable to generate or be affected by electromagnetic interference, such as:

• Information technology equipment

• Laboratory equipment

• Industrial machinery

• Electro medical equipment (in the context of Directive 93/42/EEC on medical devices)

LNE is an active member of several EMC standardization committees and Eurolab committees. French accreditation committee COFRAC approved LNE as a Notified Body for the EMC Directive and carries out EMC tests according to EN 60601-1-2.

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.

Test your medical product To request a proposal, Contact us.

EN 60601 Guide

LNE G MED CE Marking IVD Medical DevicesWe provide answers to the most important questions, lighting the way through the 3rd edition for manufacturers.

 

Electromagnetic Compatibility Guide

LNE G MED Electromagnetic Compatibility for Medical DevicesLet LNE/G-MED’s Guide to Electromagnetic Compatibility light the way to your electrical medical device’s CE marking, etc.

 

 

Define a Testing Strategy Guide

LNE G MED Define a Testing StrategyManufacturers/ importers: learn about the preclinical technical evaluation.

 

combo ISO 13485 9001

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.

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

Register Today!

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Santa Clara, CA