Electrical Safety
Service
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:
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.
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.
Such as for ISO 13485, CE Marking, and other certificates
With offices worldwide, you get the convenience of a local based team, who will work with you closely to define program details and ensure your timeframe is met.
Combine your certifications to reduce time and cost
Request a Medical Device Certification
We serve the medical device industry worldwide with offices in Europe and the United States.