At Fibronostics, our mission is built on a foundation of precision and trust. We are proud to announce that we have completed our latest ISO 13485:2016 audit, reaffirming our full compliance with the international gold standard for Medical Device Quality Management Systems (QMS).

ISO 13485:2016 is more than just a certificate on the wall; it is a rigorous framework that governs every stage of our product lifecycle. From initial design controls to risk-based manufacturing processes, this certification ensures that our medical devices are consistently safe, effective, and aligned with global regulatory expectations.

In the rapidly evolving landscape of HealthTech, maintaining this standard reflects the relentless discipline of our team. This achievement underscores our dedication to:

• Patient Safety: Ensuring every diagnostic tool meets the highest safety benchmarks.

• Regulatory Rigor: Meeting the strict demands of clinicians and partners worldwide.

• Continuous Improvement: Using data-driven insights to refine our quality management.

This milestone belongs to our entire team, whose teamwork and “quality-first” mindset make our innovation possible. As we look ahead, we remain committed to pushing the boundaries of healthcare with integrity and excellence.