As a company specialized in medical device development, CLEIO has been ISO 13485 certified since 2020. This certification reflects the strength of our Quality Management System (QMS) and ensures both the quality of our services and the compliance of our processes with MedTech regulatory requirements.
To maintain this certification, external audits are conducted annually. Following a successful surveillance audit last year with zero nonconformities, our QMS was fully reassessed during the triennial recertification audit. As a result, our certification has been renewed for another three years.
What Is ISO 13485?
ISO 13485 is a globally recognized standard in the MedTech industry and serves as the reference framework for quality management systems applied to medical devices.
For companies in the field, adhering to ISO 13485 means committing to patient safety, as well as to the quality and reliability of the devices they bring to market.
A Robust and Well-Documented Quality Management System
During the audit, all aspects of CLEIO’s QMS were thoroughly evaluated – from documentation to sales and purchasing, design and development, risk and change management, equipment control, and training.
At the end of the four-and-a-half-day audit, no nonconformities were identified in our core processes. Auditors consistently highlighted our rigor, the level of detail in our documentation, and the strength of traceability across the projects reviewed.
Their conclusion: a solid, well-documented system that stands alongside leading companies in the field.
Our Quality Assurance Team
Quality at CLEIO Is Everyone’s Responsibility
At CLEIO, quality is not addressed only during audits: it is part of how we work every day, across all projects and areas of the company.
Over time, a strong quality culture has taken root, supported by engaging internal training initiatives that help teams fully understand quality requirements and integrate them into their daily practices.
Today, teams see the impact of strong quality management on project outcomes. They actively contribute to continuous improvement and the adoption of new practices.
Our Processes are Built on Continuous Improvement
“The QMS has matured significantly in recent years. Through continuous improvements, we’ve introduced new elements to strengthen our processes and refine our methods,” she explains.
These efforts have led to clearer responsibilities, stronger practices, and more structured processes.
Beyond the certification renewal, auditors also recognized our continuous efforts to maintain a high level of rigor across our processes. This recognition reflects how we work every day: as a team, with precision, and with a constant focus on improvement.