Expertise in Microbiology, Packaging, Biocompatibility & Analytical Chemistry TÜV SÜD Testing Laboratory – New Brighton, MN
Expertise in Microbiology, Packaging, Biocompatibility & Analytical Chemistry TÜV SÜD Testing Laboratory – New Brighton, MN
Meeting regulatory deadlines and overcoming supply chain challenges requires a testing partner you can trust. TÜV SÜD’s New Brighton lab, an ISO 17025-accredited and GLP-compliant third-party facility, delivers dependable, compliant medical device testing with industry-leading expertise and turnaround times. This enables you to stay on schedule and bring safe, effective products to market with confidence.
We support every stage of your device’s lifecycle, from design and verification to regulatory submission and post-market support, offering a comprehensive portfolio of independent laboratory services backed by global regulatory expertise.
Our advanced capabilities include:
These services are complemented by a wider portfolio of specialized testing, including EMC testing, and cybersecurity validation, to support every stage of regulatory compliance and product development.
Eliminate the hassle of managing multiple vendors by accessing all your medical device testing needs in one location.
While our capabilities span the entire landscape of medical device testing, the New Brighton lab is internationally recognized for advanced expertise in:
Our team includes scientists who actively contribute to the development of FDA, ISO, and MDR standards.
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Nicole Cufaude Laboratory Manager and Head of Global Service Line
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Shannon Carver Senior Quality Team Lead and Head of Global Quality for Laboratory Testing |
Tim Andrews
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Jessica Schmidt Scientific Project Manager
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Jess Stanton
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Explore our advanced capabilities in chemistry, biocompatibility, microbiology, packaging and processing validation.
Chemistry Testing Laboratory
Our Laboratory performs chemical characterization techniques such as GC-MS, HS-GC-MS, ICP-MS LC-QToF, and TOC in support of Biological Evaluation Plans and Toxicological Risk Assessments. These methods support extractables and leachables studies, material characterization, and compliance with the ISO 10993 series and global regulatory requirements for medical devices.
Reprocessing Validation
Our reprocessing lab performs cleaning and disinfection, and sterilization validations for reusable medical devices, ensuring compliance with appropriate ISO, ASTM, and AAMI standards to support safe and effective clinical reuse.
Biocompatibility Testing Laboratory
We perform ISO 10993-compliant testing, including cytotoxicity, hemocompatibility, and genotoxicity, providing safe and effective medical device evaluations.
Microbiology Testing Laboratory
We conducted sterilization validations, including bioburden, sterility, BET/LAL, and biological indicator qualification, in compliance with ISO 11737, 11135, and 11137. Additionally, we perform reusable device validation testing, including cleaning, disinfection, and sterilization studies, ensuring compliance with ISO 17664, 17665, ST98, and other regulatory requirements.
Packaging Testing Laboratory
Our laboratory validates both sterile and non-sterile packaging through comprehensive testing, including transit simulation, stability studies, and barrier integrity evaluation, to ensure compliance with ISO 11607, ASTM D4169, and ISTA series protocols.
Contact us today to schedule a meeting with our team or request a quote.
TÜV SÜD America Inc.
141 14th ST NW
New Brighton, MN 55112
Contact:
+1-651-631-2487
+1-800-888-0123
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