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Medical Device Testing
Since medical devices are subject to risk, comprehensive medical device testing throughout the entire product life
cycle is a critical step in the transformation process from an innovative design into a reliable and marketable
In accordance with ISO 10992 and ISO 18562 standards, FDA guidance, ASTM (American Society of Testing Materials)
standards and other international guidelines, STEMart’s experts with years of experience in a variety of testing
services for Class, I, II and III medical devices provides assistance for our clients to ensure that every aspect of
medical device is properly inspected.
SETMart helps manufacturers conduct a variety of In Vitro and In Vivo safety evaluation
studies according to ISO 10993 and ISO 18562 standards on medical device to identify the presence of
toxins or any other potentially harmful effects.
STEMart provides expert services to help medical device manufacturer validate terminal sterilization
processes, and evaluate methods for cleaning and reprocessing reusable devices and instruments.
STEMart provides a wide range of services, including disinfection efficacy studies, filter testing,
forced degradation, row material screening, residual manufacturing material testing, environmental
monitoring and water system validation and monitoring, to identify the potential product contamination
source in the manufacturing facility and process.
STEMart features complete capabilities to evaluate every aspect of your package to ensure your product
reaches the end user intact.
SETMart provides a wide range of physical testing services involving Electrical Safety, Functional
Safety, Electromagnetic Compatibility, Environmental Testing and Wireless Testing.
Combining a broad range of trusted In Vivo models and analysis tools with expertise with ISO and
FDA medical device regulations, SETMart provides preclinical study to help manufacturer accelerate the
development of medical devices in a range of locations across the globe.
Combining expert medical product testing knowledge with the state-of-the-art laboratories and facilities, SETMart provides a one-stop, client-specific approach for testing of both active medical devices, non-active medical devices
and In Vitro Diagnostic equipment. If you want to learn more detail about our medical device testing service, or
would like to consult with the experts at STEMart, please feel free to contact us.