Electrical Safety

To 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

GMED has developed testing equipment customized to provide medical device manufacturers with a responsive, accurate and affordable way to test medical devices.

Core Capabilities

For 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.

• Integration of Testing with Certification 

  Such as for ISO 13485, CE Marking, and other certificates.

• 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.