Yesterday Matthew O’Donnell, Associate Global Head – Orthopaedic & Dental at BSI, visited our facilities to handover the MDR Certificate.
This milestone confirms that our products meet the highest European standards of safety, quality, and clinical performance. The transition to MDR has been a rigorous process, with increased requirements in clinical evaluation, traceability, risk management, and post-market surveillance.
This achievement has only been possible thanks to the teamwork and dedication of our entire staff, as well as the collaboration with our external partners and BSI, one of the most reputable Notified Bodies worldwide. Working with BSI not only raises the level of regulatory demand but also strengthens the credibility and robustness of our products in global markets.
As Mattew O’Donnell said:
“The MDR Regulation is critical for any manufacturer that wishes to place its medical devices on the market in the European Union and BSI is committed to supporting organizations with this challenge. Achieving certification to the MDR, demonstrates that an organization has established processes that consistently meet customer and applicable regulatory requirements, ensuring timely market access to safe medical devices. Congratulations to all the GMI family on this achievement.”
The MDR certification is not just a recognition of compliance — it is a reaffirmation of our commitment to excellence and continuous improvement, for the benefit of the patients and professionals who place their trust in GMI.
This accomplishment marks a new beginning, inspiring us to maintain a strong, evidence-based and vigilant management system, and to continue overcoming future challenges together.
? Congratulations to everyone! This success belongs to all of us.
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