After years of dedication and hard work, our organization has successfully achieved Medical Device Regulation (MDR) certification. This achievement is a testament to the commitment, resilience, and expertise of our teams, who have tirelessly worked together to ensure our products meet the highest safety and quality standards.

At DIXI medical, we are deeply committed to making the necessary investments to ensure we remain a reliable, long-term partner for the healthcare sector in Europe. Our products, proudly made in Europe for patients around the world, reflect our dedication to quality and innovation. Our strong presence in the European market is a key differentiator, underscoring our unwavering commitment to maintaining the highest standards of excellence across all aspects of our business.

The process to achieve MDR compliance was a long and resource-intensive effort that began years ago, focusing on updating the technical documentation for our MICRODEEP® product family. Over 16 team members from our Regulatory Affairs, Quality Assurance, and R&D departments led this project, supported by other teams, including Methods, Quality Control, Production, and Marketing. More than 20,000 hours were spent over the past three years only to bring this project to completion. The MICRODEEP® dossier alone represents a volume of seven full binders.

“Achieving MDR certification is a significant milestone for DIXI medical and it reflects the collective effort and commitment of our teams. This accomplishment required years of focused work, attention to detail, and a strong understanding of the evolving regulatory environment.

While this certification is an important achievement, it also marks the start of a new chapter where continuous compliance and adaptability will be key. We are prepared to navigate the challenges ahead, confident that our teams’ expertise will help us maintain the highest standards in safety, quality, and innovation as we move forward,” said Frédéric Koehn, CEO DIXI medical.

Sustaining compliance will involve keeping the regulatory documentation up to date, providing specialized training, and ensuring effective communication and transparency across all departments. We are fully prepared to meet these challenges head-on, embracing this “new normal” with a proactive and strategic approach. Our MDR certification is not only a recognition of the work we’ve done but also a commitment to the future, where compliance, safety, and innovation continue to be at the heart of everything we do.

Nicolas Roche, VP Sales and Marketing added: “The MDR certification reinforces our reputation for producing top-tier quality products and strengthens our global leadership. We are proud to be the first SEEG electrode company to achieve MDR certification, a clear testament to our leadership and the seriousness with which we approach compliance and innovation. Hospitals around the globe can count on DIXI medical as a reliable partner.”

Thank you to all our teams, partners, and supporters for helping us reach this significant milestone. Together, we are moving forward with confidence into this new regulatory landscape!