TÜV SÜD is expanding its Medical & Health Services (MHS) facilities in New Brighton, Minnesota. The 20,000 square foot laboratory extension of its existing 36,000 square foot test facility will be completed by June 2022, offering end-to-end testing for all medical devices. The laboratory also provides biological and chemical testing of medical devices complementing TÜV SÜD's current active medical device testing capabilities.
The new addition lets TÜV SÜD provide faster turnaround times on healthcare equipment and medical device testing. This also lets TÜV SÜD provide clients with up-to-date solutions to meet the evolving regulatory requirements of the medical device industry.
Specialty features of this expanded facility include:
- Instrumentation required to perform the complete range of biocompatibility testing according to ISO 10993
- Sterilization validations of various modalities for vaporized hydrogen peroxide, ethylene oxide, steam, and other substances
- Sterile packaging and transportation simulation services
“TÜV SÜD is dedicated to delivering a full-featured customer experience and offering a suite of services that enables our medical device customers to meet their quality and time to market needs,” John Tesoro, President and CEO of TÜV SÜD Americas, says. “This expanded laboratory will further enhance our ability to deliver on our commitment to our customers and complements our existing testing and notified body services.”
“This expansion to our global network of testing facilities will serve as the primary hub for service delivery to our customers throughout the Americas and will address the compliance and certification needs of healthcare equipment and medical device manufacturers throughout the region,” Adam Menzies, TÜV SÜD Director of North American Medical and Health Services, says. “We are also committed to being a catalyst for economic growth in New Brighton by opening 26 high-skilled job opportunities to the community in 2022 and aiming to provide more opportunities in the years to come.”
Representatives from the Medical Alley Association, a global leadership organization and healthcare industry partner, attended the groundbreaking ceremony.
“TÜV SÜD’s expanded facility in New Brighton is an exciting addition to Medical Alley’s world-leading, innovative medical device industry,” Medical Alley CEO Roberta Dressen says. “We are proud that they have decided to create this facility in The Global Epicenter of Health Innovation and Care.”
TÜV SÜD’s team offer accurate and efficient testing solutions to deliver timely and compliant results. It will be ISO 17025 accredited and Good Laboratory Practice compliant.