Innovation has always defined us and once again, we’re ready to take the next step forward: we proudly announce the achievement of MDR certification.
The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), also known as EU Regulation 2017/745, represents a key evolutionof the European regulatory framework for the medical sector.
Compared to the previous MDD, the MDR Regulation strengthens key aspects such as the supervision of notified bodies, risk classification, conformity assessment procedures and clinical evidence requirements. It also introduces measures to ensure greater transparency and traceability, improving the management and safety of medical devices.
This change brings with it major challenges for manufacturers. At AT-OS, we are completing the final steps to fully align with MDR standards, ensuring all of our processes, products, and documentation meet the new regulatory requirements.
Our goal is clear: to continue delivering safe, high-performance medical devices while guaranteeing full compliance and long-term reliability for hospitals and healthcare professionals.
What does this mean for our customers?
With this certification, we confirm our commitment to providing safe and innovative medical devices that fully comply with European regulations.
This advanced standard reduces risks and increases protection for users, whether they are professionals or patients.
A Continuous Path to Excellence
Achieving MDR certification marks another step in our journey of innovation and continuous improvement. We will continue to invest in research, development and training to offer state-of-the-art solutions, guaranteeing reliability and satisfaction to our customers.
This achievement confirms our commitment to excellence and ensures the quality of our products for customers and partners.
