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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 product.

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.

Medical Device Testings

Biocompatibility Testing >

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.

Microbiology & Sterility >

STEMart provides expert services to help medical device manufacturer validate terminal sterilization processes, and evaluate methods for cleaning and reprocessing reusable devices and instruments.

Facility & Process Validation >

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.

Packaging Solutions >

STEMart features complete capabilities to evaluate every aspect of your package to ensure your product reaches the end user intact.

Physical Testing >

SETMart provides a wide range of physical testing services involving Electrical Safety, Functional Safety, Electromagnetic Compatibility, Environmental Testing and Wireless Testing.

Preclinical Medical Device 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.

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