Medical Devices and In-Vitro Diagnostic (IVD) Medical Devices Testing

At TÜV SÜD, we combine expert medical product testing knowledge with a global network of internationally accredited laboratories and facilities, providing a one-stop solution. Our testing regimen subjects your product to a comprehensive evaluation in line with the rigorous standards of the medical devices industry, which serves as a testament to your product’s compliance with global standards & regulations.

Our testing suite spans the entirety of your design & production cycle - from prototype testing to CB certification and lab tests for ergonomic, electrical, mechanical, and functional safety assessments, as well as software testing, to ensure a holistic review of your medical devices.

Our experts thoroughly analyze physical performance, chemical composition, microbiological factors, and potential risks. Through rigorous tests, we ensure that your medical devices adhere to global regulations and are safe for use in healthcare settings. With TÜV SÜD's proven track record, you can be rest assured that industry professionals and consumers globally will recognize your medical devices for their functionality and safety.

TESTING INFRASTRUCTURE

• Complete EMI / EMC testing with a 10m Semi-Anechoic chamber for the standard EN / IEC 60601-1-2 and all EN / IEC 60601-2 standards.
• Sophisticated Wireless testing facilities to support regulatory requirements of Bluetooth, WiFi, SRD and Cellular technologies. Major standards supported include ETSI / EN 300 328, ETSI / EN 301 893, ETSI/EN 302 502, ETSI/EN 300 220, ETSI/EN 300 330, ETSI/EN 300 440, FCC Part 15, Part 22, Part 24, RSS standards.
• Electrical / Medical safety test facilities to test most medical products for national and international requirements.
• Comprehensive Environmental simulation test facilities for temperature, humidity, altitude, thermal shock, shock & vibration, combined vibration, water, and dust facilities.