Medical Devices And IVDs Testing

TESTING SERVICES TO STREAMLINE MARKET ENTRY FOR MEDTECH INNOVATIONS

TÜV SÜD, a leader in the U.S. and globally, understands the challenges medtech manufacturers face in navigating complex regulatory landscapes. With a commitment to reliability, transparency, and efficiency, we provide comprehensive testing services for the medtech industry.

As a one-stop solutions provider, we combine expert medical product testing knowledge with a global network of accredited laboratories, including our lab in New Brighton, Minnesota.

Testing Labs:

We offer comprehensive medical device testing with a strong emphasis on biocompatibility, chemical characterization and microbiological analysis. We specialize in biocompatibility and chemical characterization to assess the potential impact on patient safety, as well as detailed microbiological evaluations to ensure safety against contamination. 

Dedicated Team:

Our team prioritizes excellence in testing, fast turnaround and exceptional customer service.  We recognize the impact of delays and strive to meet launch timelines without compromising safety or quality. By focusing on effective project management and customer communication, we ensure clients are informed throughout the process. 

List of Testing Services for medical devices & IVDs: 

Chemical / Biological Testing

• Biocompatibility Testing
• Chemical Characterization
• Toxicological Risk Assessment

Microbiological Testing

• Sterility Assurance Testing
• Reusable Device Testing / Reprocessing Validation

Cybersecurity Testing

• Cyber Security Testing and Assessment Services
• Medical Devices & IVDs Security Testing (Penetration Testing)

Physical Testing

• Electrical Safety Testing
• MRI Safety Testing
• Functional Safety
• EMC Testing
• Environmental Testing
• NRTL
• IECEE CB Scheme

With TÜV SÜD, navigate the regulatory maze with confidence and accelerate your path to market.

Contact us to learn more