Testing and Compliance
| Associated Research | ||
Omnia is a six-in-one electrical safety compliance analyzer - hipot, ground bond, line leakage and more. |
Linechek II is our stand-alone line leakage tester - use stand alone or as part of a custom system. |
Complete medical electrical safety test system - cost-effective, scalable and efficient. |
| Berlin Cert | ||
Berlin Cert remains at the cutting edge of laboratory test procedures, continually developing and revising existing tests and standards. |
Berlin Cert tests the safety and performance-related product functions of an extensive range of active and non-active medical devices. |
Berlin Cert provides effective quality management which is tailored to the specificities of the enterprise. |
| IMR Test Labs | ||
IMR Test Labs offer a complete scope of materials research and testing services for medical devices and components. |
The product testing group is capable of evaluating almost any medical device for safety, quality, and performance. |
Failure analysis reports provide a clear picture of the root cause, and include recommendations to avoid future failures. |
IMR have numerous analytical tools at their disposal, all geared toward providing accurate, NIST traceable analyses of metals and process solutions. |
The polymer analysis department is equipped with state-of-the-art equipment for polymer analysis and characterization. |
|
| Massachusetts Materials Research | ||
Metallurgical investigation at MMR determined the cause of this of hip joint failure shown here in an x-ray image. |
Fatigue fracture of dental needle that failed in patients jaw due to cyclic bending during injection. |
We implement mechanical medical device implant testing, such as the femoral hip implants being tested here. |
The scanning electron microscope with energy dispersive spectroscopy is an analytical tool used for high magnification examination and microchemical elemental analysis. |
MMR is a fully equipped, 22,000ft² laboratory facility with a professional staff specializing in materials testing, mechanical testing and engineering. |
|
| TÜV SÜD America | ||
The Medical Health Services unit of TÜV Product Service offers a variety of global compliance services that help ensure your products' acceptance and success. |
Our Medical Health Services unit is the premier notified body for medical devices globally. |
TÜV SÜD is an accredited Management Systems Registrar in the US, Eu-rope and Asia. |
| Tinius Olsen | ||
Tinius Olsen is one of the world’s foremost specialist manufacturers of testing machines for the medical device industry. |
A complete series of physical tests are available for medical devices. |
Tinius Olsen has been manufacturing, servicing and calibrating testing equipment of the highest quality since 1880. |
| Zwick | ||
Zwick has recently worked with many global organisations that develop products for cardiovascular surgery. |
Zwick provides complete complex material and component testing solutions. |
We have developed a special horizontal material-testing machine for the cardiovascular industry. |
Zwick's expanded traceability option, meeting FDA 21 CFR part 11, is fully integrated into its testXpert® II modular software. |
We provide our customers with IQ / OQ support. |
|
