For the Record with Nicole Cufaude, Laboratory Manager and Head of Global Service Line – Medical Device Testing, TÜV SÜD

News, press release

August 4, 2025

1. What is TÜV SÜD?

TÜV SÜD is a global provider of technical services, including testing, certification, auditing, and training, in various industries, with a strong focus on healthcare and medical devices.

Within the medical device sector, TÜV SÜD plays a pivotal role in enabling innovation while ensuring compliance with regulatory requirements, from FDA 510(k) submissions to achieving EU CE marking under MDR. Our testing services, which are independent of our certification services, provide valid test results required for regulatory approval and streamline global market access. We’re proud to have one of our global Centers of Excellence for medical device testing located in the heart of Medical Alley, right here in New Brighton, MN.

2. What about TÜV SÜD’s work and impact makes you the most proud?

I’m most proud of TÜV SÜD’s ability to bring together deep technical expertise, global collaboration, and an unwavering commitment to patient safety. Working in a test facility like ours offers a unique advantage; we’re exposed to a broad and diverse portfolio of medical devices, from early-stage innovations to highly complex systems. This variety not only keeps our work intellectually stimulating, but it also provides us with a broader perspective on industry trends and challenges. We’re not just testing products; we’re supporting innovation across the healthcare spectrum while ensuring the highest standards of quality and regulatory compliance. It’s significant to know that our work plays a direct role in improving—and often saving—patients’ lives around the world.

3. What is on the horizon for TÜV SÜD? What is something exciting people can expect to see from the organization in the near future?

TÜV SÜD continuously invests in expanding its global laboratory network and technical capabilities, with a strong focus on areas such as biological safety, extractables and leachables, and testing for alternative sterilization modalities. One exciting area of focus is harmonizing processes and building operational centers of excellence, such as our state-of-the-art testing facility located here in New Brighton, MN. These centers ensure a consistent and high-quality client experience worldwide, regardless of their location. This includes optimizing turnaround times and providing dedicated client support.

4. Tell us about your professional journey in the healthcare industry. How did you first get involved and what were some of the key moments that led you to working with TÜV SÜD?

Nicole Cufaude, Laboratory Manager and Head of Global Service Line – Medical Device Testing, TÜV SÜD

My journey in the healthcare industry began over 20 years ago, when I started as a technician in a microbiology laboratory at a medical device manufacturer. I spent 17 years with that organization, advancing through various roles and ultimately serving as the Senior Manager of Sterilization and Microbiology. That experience gave me a deep foundation in laboratory science, regulatory compliance, and. leadership, and it prepared me for one of the most pivotal transitions in my career, joining TÜV SÜD.

At TÜV SÜD, I had the opportunity to broaden my scope and impact significantly. I began by designing and building the Minnesota laboratory from the ground up, recruiting a talented team and establishing operations across Microbiology, Biocompatibility, Chemistry, and Packaging. Over the following years, I was entrusted with increasing global responsibilities, and I now lead the service line for medical device testing laboratories worldwide. This role has enabled me to leverage my cross-disciplinary background on a global scale.

A defining moment for me was recognizing the essential role of standardized, high-quality testing in global patient safety. Knowing that our work directly supports life-saving medical devices is both humbling and motivating. I’m proud to contribute to that mission every day.

5. What’s the biggest challenge you’ve faced as a leader and how did you navigate it?

One of the biggest challenges has been leading teams through rapid change, whether due to regulatory shifts, client priorities, or global growth. Navigating requires transparency, empathy, and a strong focus on communication. I’ve achieved success by building trust within my team, cross-functional partners, and leadership, empowering the team, and maintaining a clear vision that ties our work back to both our values and our impact on patient health.

6. What advice would you give to aspiring healthcare leaders who are looking to make a lasting impact?

Never stop learning. Surround yourself with experts, ask questions, and foster a culture where collaboration and innovation are encouraged. Your ability to lead with both technical and emotional intelligence, especially in highly regulated spaces, will set you apart.

7. Outside of your career, what are some of the favorite ways to spend your time?

I enjoy spending time with my family. We love to hike, dance, play games, and explore new places. Time away from work helps me recharge and return with a fresh perspective. I also enjoy mentoring young professionals on the STEM committee. I have had many wonderful mentors throughout my career, and I always try to pay it forward.

8. What do you appreciate most about being part of the Medical Alley community?

Medical Alley provides an incredible network of innovators, leaders, and changemakers who are shaping the future of healthcare. What I value most is openness and collaboration across disciplines. It’s a place where people genuinely want to learn from one another, share ideas, and raise the bar for what is possible in patient care.

9. How do you see the healthcare industry evolving in the next 5-10 years?

We will see a much stronger integration of digital technologies into medical devices, from smart sensors and AI-supported diagnostics to personalized medicine. At the same time, global regulatory frameworks will become more interconnected and data-driven. As healthcare innovation accelerates, choosing the right testing lab becomes more critical than ever. Manufacturers require partners with both technical expertise and regulatory insight to bring safe and effective devices to market with confidence.

10. How can the Medical Alley community rise to face those changes and challenges?

By continuing to foster collaboration across sectors, whether startup, enterprise, regulatory, or clinical. Medical Alley holds a unique position as a hub that connects innovation with real-world implementation. Investing in workforce development, regulatory education, and cross-functional partnerships will be essential to navigating the changes ahead.

11. Can you discuss any recent trends in medical device testing that have emerged due to regulatory changes or new technologies?

One key trend is the increasing demand for comprehensive chemical characterization and extractables/leachables testing, particularly due to evolving FDA and ISO 10993 expectations. There’s also more emphasis on risk-based approaches and real-time data integration. In the microbiology side, we’re seeing rising expectations around method validation and sterility assurance for complex combination products. Test labs need to be agile, multidisciplinary, and forward-thinking to keep pace with these shifts.

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