This website and all information published on it are managed in accordance with our Quality Management System (QMS), including the requirements of ISO 13485:2016 and the applicable provisions of the EU Medical Device Regulation (EU) 2017/745 (MDR) related to controlled communication, product information, and public presentation of medical devices.

Control of Website Content
All website content—including product descriptions, technical specifications, instructions, claims, organizational information, and regulatory statements—is subject to formal Document and Change Control processes.
Only authorized personnel are permitted to create, revise, or approve content prior to publication. Each update follows a documented and traceable approval workflow to ensure:

• Accuracy and completeness of the information
• Consistency with approved labelling and technical documentation
• Compliance with regulatory requirements governing medical‑device information
• Alignment with current, approved QMS documentation

Ongoing Review and Monitoring
Website content is periodically reviewed to verify continued accuracy and relevance.
If deviations, outdated information, or inconsistencies are identified, corrective actions are initiated in accordance with our Nonconformity procedures, ensuring timely correction and prevention of recurrence.

Data Integrity and Access Control
We maintain appropriate technical and administrative controls to protect the integrity and security of website data.
Access to the content management system is restricted to designated personnel with controlled user rights. Unauthorized changes are prevented through system safeguards, audit trails, and periodic access‑rights reviews.

Commitment to Compliance
We affirm that, to the best of our knowledge and based on our controlled processes, all information currently displayed on this website is accurate, approved, and under documented control within our QMS.
Any concerns related to the accuracy of information on this website can be reported here.