Demax's Management Approach

Demax Medical complies with applicable laws, directives, regulations and other requirements of design, purchasing, production and inspection as a baseline for doing business. We believe compliance is owned by all employees, and will monitor such compliance through regular assessments and audits of our operations, take corrective actions as warranted, and include compliance sustainability as a routine part of operations.

Demax Medical reviews the quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This management approach includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objective. In order to facilitate this, Demax Medical provides appropriate training and resources for employees to use responsible practices.

The quality management system of Demax Medical has been audited and certificated by ISO13485, a globally recognized standard following the format of ISO9001 for the convenience of users in the medical device community, established by the International Standards Organization. The ISO13485 specifies requirements for a quality management system that can be used by Demax Medical for the design and development, production, installation and servicing of medical devices for interventional surgery, and the design, development, and provision of related services. The system includes elements of quality management, management responsibility, resource management, product realization, measurement, analysis and improvement.