New Brighton, MN, USA - June 8, 2022 | 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.
TÜV SÜD also offers a range of device testing services, including electromagnetic compatibility (EMC) and biocompatibility testing solutions. As an accredited NRTL certification provider and an ISO/IEC 17025:2017 certified laboratory, TÜV SÜD can conduct a variety of conformity assessments to help strengthen a competitive position in the market. For more information regarding MRI testing or any of TÜV SÜD's other services, visit our website or contact us at [email protected].
Demand Generation and Content Manager – Healthcare and Medical Devices
TÜV SÜD America Inc.
Phone: +1 (347) 263-0746
Email: [email protected]
About TÜV SÜD
TÜV SÜD is a premium quality, safety, and sustainability solutions provider that specializes in testing, inspection, auditing, certification, training, and knowledge services. Since 1866, the company has remained committed to its founding principle of protecting people, property, and the environment from technology-related risks. Headquartered in Munich, Germany, TÜV SÜD is represented in more than 1,000 locations worldwide. TÜV SÜD operates globally with a team of more than 24,000 multi-disciplinary experts recognized as specialists in their respective fields. By combining impartial expertise with invaluable insights, the company adds tangible value to businesses, consumers, and the environment. The aim of TÜV SÜD is to support customers with a comprehensive suite of services worldwide to increase efficiency, reduce costs and manage risk.
About TÜV SÜD America
TÜV SÜD America Inc., a subsidiary of TÜV SÜD AG (Munich, Germany), is a leading globally recognized testing and certification organization. TÜV SÜD's Business Assurance division provides management system certification services to ISO 9001, ISO 14001, AS9100, Safe Quality Food (SQF), and more. TÜV SÜD's Product Service division offers electrical and mechanical product safety, Electromagnetic Compatibility (EMC) testing, environmental testing, NRTL and SCC accredited certification, CE marking assistance, restricted substance services, international compliance services, and more. TÜV SÜD America also provides a comprehensive suite of services for the medical device sector as a European Union notified body for the medical device, active implantable medical device and in-vitro diagnostic device directives, and a complete service portfolio including ISO 13485 and MDSAP certification, FDA 510(k) and third-party inspections. The company's Industry Services division offers a full suite of services for pressure equipment manufacturers and materials producers exporting products to the European Community. The Industry Services division also includes TÜV SÜD Global Risk Consultants, the leading global provider of unbundled property loss control services.