Medical device testing center of excellence

Explore TÜV SÜD’s medical device testing center in New Brighton, with expertise in microbiology, packaging, biocompatibility and chemistry services.

Author's Profile

TÜV SÜD Expert

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:

Microbiological testing
Biocompatibility testing
Medical device packaging testing
Chemical characterization & analytical chemistry
Reprocessing validation for reusable devices
MRI safety testing

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.

Need more reasons to choose TÜV SÜD New Brighton?

Reliable Turnaround: Consistent quality, data integrity, and dependable timelines
One Partner, Global Access: Independent testing, certification, and regulatory support
Trusted Expertise: Scientists active in global standards and regulatory committees
Dedicated Support: project management and expert guidance with clear, proactive communication throughout your project

Eliminate the hassle of managing multiple vendors by accessing all your medical device testing needs in one location.

In this industry, every day matters. That’s why we build lab systems and teams that our clients can count on, to move from concept to commercialization with confidence and assurance.

Nicole Cufaude

Head of Global Service Line

Internationally recognized specializations

Analytical chemistry

Chemical Characterization or Extractables & Leachables (E&L (ISO 10993-18)
Targeted Elemental and Metals Analysis
Total Organic Carbon (TOC) Analysis
Custom Chemistry Testing
Ethylene Oxide (EO) Residuals Testing
Alternate Sterilization Modality residual testing
Biocompatibility Evaluation of Respiratory Devices (ISO 18562 Series)

Microbiology

Bioburden Testing
Product and BI Sterility Testing
Bacterial Endotoxin Testing (BET / LAL)
Reusable Device Validation (Cleaning, Disinfection, Sterilization)
Sterilization Validation Testing
Water Testing
Incubation and Enumeration

Biocompatibility

In Vitro and In Vivo Studies
Cytotoxicity
Irritation
Sensitization
Acute Systemic Toxicity
MMP
Hemocompatibility
Genotoxicity
Toxicological Risk Assessment (TRA)

Packaging

Accelerated & Real-Time Aging
Strength Testing
Integrity Testing
Sterile Barrier Testing
Transportation Simulation & Distribution Testing (ISTA)
Shelf-Life Validation

Meet our team of experts

Our team includes scientists who actively contribute to the development of FDA, ISO, and MDR standards.

Nicole Cufaude

Laboratory Manager and Head of Global Service Line

Shannon Carver

Senior Quality Team Lead and Head of Global Quality for Laboratory Testing

Tim Andrews
Team Lead and Study Director – Chemistry

Jessica Schmidt

Scientific Project Manager

Jess Stanton
Principal Study Director – Technical Lead

Specialized medical device testing laboratories

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.

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