Medical Device Mechanical and Performance Testing
Mechanical and performance testing comprise a crucial component of medical device registration and approval processes in the US, Europe and other major markets. Performance testing provides objective confirmation of performance claims and/or regulatory requirements by simulating intended usage of a device in a controlled laboratory setting.
Common mechanical and performance tests required for medical devices
Emergo, and our parent company UL, are experts in performance and mechanical testing, and can help you determine the exact regulatory requirements for your device. UL has developed technical expertise for a vast array of device types. Depending on the characteristics of your medical device, our performance testing services include:
- Accelerated stress testing (AST)
- Benchmark and comparison testing
- Usability testing (links to HFE page)
- Failure analysis
- Materials testing
- Dimensional stability
You should carefully consider your devices’ design and performance characteristics as well as specific regulatory requirements of the markets you are targeting. Depending on these factors, we can help you identify which performance tests should be conducted on your device.
How we can help you meet your mechanical and performance testing obligations
We offer performance tests according to current consensus standards, as well as testing developed according to your own internal protocols. Our testing portfolio includes functional and engineering evaluations of finished devices as well as their component materials.
Performance and mechanical tests provide measurable performance data to suit regulatory requirements, risk mitigation and product improvement purposes. They also allow verification of performance and function claims to address regulatory questions and bolster your competitive advantage.
Contact us for more information on medical device performance and mechanical testing services