At Cook Research Incorporated (CRI), being “first” isn’t about recognition—it’s about improving how quickly safe, effective medical devices reach patients.
In 2025, CRI became the first U.S.-based company to earn certification to ISO 14155, an international standard that defines how clinical studies on medical devices should be designed, conducted, and reported. The standard focuses on protecting patients, ensuring high-quality data, and maintaining ethical research practices.
For CRI, pursuing this certification was a natural extension of its role supporting Cook Medical. The global Clinical Affairs team designs and runs clinical studies that help demonstrate whether new medical devices are safe and effective—an essential step before those devices can be approved for patient use.
Why this certification matters
Medical device companies can conduct clinical studies without ISO 14155 certification, as long as they follow applicable regulations. However, certification provides independent verification that those studies meet globally recognized best practices.
“Regulators want to know they can trust the data they’re reviewing,” said Josh Hawkins, who served as CRI’s Quality Assurance director during the certification process. “This certification shows that our processes—from how studies are designed to how data is collected and analyzed—meet a very high standard.”
That confidence can help streamline interactions with regulatory agencies like the U.S. Food and Drug Administration, ultimately supporting more efficient pathways to approval.
What it takes to earn ISO 14155 certification
The certification process is rigorous and comprehensive.
ISO 14155 covers every aspect of a clinical study involving human participants, including:
- How studies are planned and approved
- How research sites and participants are selected
- How data is collected, monitored, and verified
- How results are analyzed and reported
- How patient safety and ethical standards are maintained
To achieve certification, CRI worked with TÜV SÜD, an independent organization that audits companies against international standards.
The effort took about six months of preparation, followed by both remote and in-person audits before certification was awarded. The process included:
- A detailed review of CRI’s procedures and documentation
- A multi-day, on-site audit with independent reviewers
- Interviews with subject matter experts across the organization
- Verification that systems for data collection, storage, and reporting met strict requirements
“It’s truly everything,” said Dan Martin, senior manager of CRI’s Clinical Infrastructure team. “Every step of how a clinical study is run is evaluated—from the first plan to the final report.”
A proactive approach to quality
Previously, CRI demonstrated alignment with ISO 14155 through its broader quality certification (ISO 13485). However, evolving industry rules meant that approach would no longer be sufficient.
Rather than simply removing that reference, CRI chose to pursue standalone certification.
“We wanted to be clear and transparent about the standards we follow,” Hawkins said. “When the opportunity came to be certified directly, we saw it as the right step—not just for compliance, but for leadership.”
Supporting faster access to innovation
While CRI primarily supports internal work for Cook Medical, the impact of this certification extends beyond the organization.
More than just a piece of paper, this certification highlights CRI’s commitment to:
- Consistently design and run studies to the highest quality standard
- Reduce questions from regulators by strengthening the credibility of methods followed and clinical data collected
- Improve efficiency in the approval process
- Support faster access to new medical technologies for patients
A culture of innovation and collaboration
Achieving this milestone required coordination across teams in multiple countries, including contributors from Europe and Australia who participated across time zones.
“It was absolutely an all-hands effort,” Martin said. “We relied on experts across the organization to make this happen.”
The initiative also reflects a broader mindset within CRI and Cook Medical—one focused on continuous improvement and taking on new challenges.
“We don’t just want to follow what’s already been done,” Martin said. “We want to find better ways to get high-quality devices to the patients who need them.”
FAQ
What is ISO 14155?
ISO 14155 is an international standard that outlines best practices for clinical studies of medical devices involving human participants. It ensures studies are conducted ethically, safely, and with reliable data collection and reporting.
Why is this certification important?
Certification provides independent confirmation that a company’s clinical research processes meet global standards. This helps build trust with regulators, healthcare providers, and patients.
Does this change how clinical studies are conducted?
CRI was already following these principles. Certification formally verifies and strengthens those practices through independent review.
How does this benefit patients?
By improving the quality and consistency of clinical research, certification helps ensure that medical devices are evaluated thoroughly and efficiently — supporting faster access to safe and effective treatments.
Who provides the certification?
Independent organizations, sometimes called certification bodies, audit companies against international standards. In this case, CRI worked with TÜV SÜD.
Does this mean devices are approved faster?
Not automatically. All devices must still meet regulatory requirements. However, high-quality, trusted data can help reduce delays during the review process.