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Electrical Safety

Notified Body Testing Electrical SafetyTo ensure product safety and reliability, medical devices must be tested to verify a variety of standards, including:

• Protection against electrical shocks
• Insulation
• Marking
• Documentation
• Construction
• Usability

 

LNE/G-MED has developed testing equipment customized to provide medical device manufacturers with a responsive, accurate and affordable way to test medical devices.

Core Capabilities

testing electrical safetyFor all electrical equipment, LNE's experienced technical team can provide you with:

  • Testing in order to complete your technical file and meet the essential requirements of European Directives for CE marking
  • Expert advice on ensuring product conformity
  • Expert analysis of a product following a failure
  • Performance assessment, such as for prototype testing

Our technical team can provides testing on all electrical equipment operating in a range of 50 to 1000 volts, including such devices as:

  • Medical beds
  • Operating tables
  • Ventilators
  • Radiological equipment
  • Electrical stimulators
  • Endoscopes

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 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