Quality Our Certificates
At ZESA, we consider reliability, quality, and patient safety to be our core priorities. With this understanding, we possess various accreditations and quality management systems that certify that our products and services are manufactured and managed in accordance with the highest international standards.
Our production and quality control processes are regularly audited by independent and internationally accredited auditing organizations, and the continuity and effectiveness of our systems are meticulously monitored.
CE Certificate
ZESA products bear the CE mark, indicating compliance with European Union directives and regulations. This certification demonstrates that our products are entitled to free circulation within the European Economic Area and meet essential health, safety, and environmental requirements.
ISO Certificate
ZESA implements a quality management system compliant with the ISO 13485 standard, specifically developed for the medical sector. This document ensures consistency, risk management, and continuous improvement throughout all processes, from the design and manufacture to the distribution and technical servicing of medical devices.