Medical Device Physical Testing

Since medical devices are subject to risk, determination of the physical properties of medical device is a critical step in the transformation process from an innovative design into a reliable and marketable product.

Based on the complete knowledge of regulation, guidelines and standards, STEMart provides a one-stop physical testing service to help manufacturer demonstrate the compliance of their medical device with requirements specified in EMC Directive 2014/30/EU, FDA guidance and International Electrotechnical Commission (IEC) standards, etc., thereby, boosting the trust in their product.

Physical Testing

Electrical Safety Testing

The IEC 60601-1 states the safety requirements of medical device. SETMart provides the full range of electrical safety testing according to the IEC 60601-1 to ensure the medical device is electrically safe for patients and users in hospitals, clinics, therapy centers and similar healthcare environment.

Functional Safety Testing

STEMart provides various functional safety testing according to IEC 61508 and software (stand-alone or as an embedded or integral part of the final medical device) lifecycle processes evaluation according to IEC 62304.

Electromagnetic Compatibility (EMC) Testing

STEMart provides comprehensive range of electromagnetic compatibility (EMC) testing to gauge the ability of medical device to function as it should in the electromagnetic environment without generating an intolerable electromagnetic reaction, as well as EMC certification.

Environmental Simulation Testing

STEMart offers comprehensive environmental simulation testing which simulates various climatic conditions and mechanical stress that medical device may be exposed to during their lifetime to identify the weakness in the design and performance of this product. Environmental simulation testing can help manufacturer initiate product improvement at the early stage, thereby increasing the product compliance with international regulations.

Wireless Testing

SETMart provides a wide range of wireless testing for wireless radio and wireless power transfer (WPT) device, such as FDA wireless coexistence testing, 5G compliance testing, radio frequency (RF) testing, electromagnetic field (EMF) testing, bluetooth qualification testing, etc. to help manufacturer meet regulatory requirements, reduce the risk of costly non-compliance and improve product performance.

Mechanical Properties Testing

STEMart provides manufacturers with a variety of mechanical testing services to reveal the properties of a material or medical device under static or dynamic force, such as tensile strength, ductility, compression strength, peel strength, fracture toughness and fatigue.

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 physical testing service, or would like to consult with the experts at STEMart, please feel free to contact us.

Physical Testing

Physical Testing

Electrical Safety Testing

Functional Safety Testing

Electromagnetic Compatibility (EMC) Testing

Environmental Simulation Testing

Wireless Testing

Mechanical Properties Testing

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