TÜV SÜD Establishes State-of-the-Art Laboratory for MRI Safety Testing of Medical Devices in the USA
TÜV SÜD, a trusted global partner offering a comprehensive portfolio of testing, certification, and auditing services, recently announced their Scope of Accreditation to ISO/IEC 17025:2017 granted by the American Association for Laboratory Accreditation (A2LA), recognizing the completion of the assessment process to perform MRI Safety testing services.
MRI Safety Testing is crucial for medical devices used within a magnetic resonance imaging (MRI) environment. By submitting active and passive medical devices and implants to these tests, manufacturers can now receive specific insights on MRI safety and compatibility, as well as associated labeling information for premarket submissions.
"With the addition of our MRI Safety Testing laboratory, we continue to expand our state-of-the-art test and certification solution portfolio for the medical device industry to serve our customers better today and for decades to come. Innovation and a customer-centric approach are the key drivers that make us a trusted advisor to some of the country's most innovative medical device companies," said John Tesoro, President, and CEO of TÜV SÜD Americas.
The MRI Safety Testing laboratory is an extension to more than 55,000 square feet of facilities in New Brighton, MN, offering end-to-end testing solutions for all medical devices.
Krishna Singhal, Ph.D., and Technical Lead for TÜV SÜD's MRI Safety group explains, "We have established a state-of-the-art laboratory to perform MRI Safety testing for medical devices at both 1.5T and 3T. We can assess for RF-induced heating, magnetically induced force, torque, image artifact and provide labeling for medical devices."
"By opening an MRI Safety Testing laboratory, TÜV SÜD ensures a complete customer experience by offering a set of services that allow our medical device customers to have their needs met with quality and time to market," said Adam Menzies, TÜV SÜD Director of North American Medical and Health Services.
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