Quality Assurance Policy

Fanem is committed to meeting the needs and expectations of our customers. This level of Quality is achieved through the development of innovative products, high level of customer service and the adoption of a Quality system in accordance with ISO 13485, ANVISA’s Good Manufacturing Practices and the European Medical Devices Directives. Maintaining risk assessment activities by providing appropriate and adequate resources for proper implementation and maintenance of process risk management. We are committed to maintaining the effectiveness of the Quality Management System. In addition, our products will meet applicable standards and regulatory requirements.

OUR QUALITY GOALS

We achieve our goals by managing, measuring and continually improving all spheres of our organization including:

• Long-term relationships and trust with our employees, suppliers and customers
• Skills and knowledge
• Equipment, methods and procedures used
• Operational results
• Improving our quality management system in alignment with the requirements of ISO 13485, ANVISA’s Good Manufacturing Practices and the European Medical Devices Directives