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
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
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.
- Local Point of Contact: With offices in Washington, D.C., you get the convenience of an American based project management team, who will work with you closely to define program details and ensure your time frame is met.
Find Out More
LNE/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
