The quality of our production is guaranteed by a quality system based on the ISO-EN 13485 standard. For our customers, our quality system tells that our level of activity is regularly monitored and the requirements of laws are met. Annual audits by notified bodies ensure that our quality system complies with the standard requirements and the quality system.
The Standard EN ISO 13485 guides the design, development, production and after-sales service of medical devices and health care products. With the quality system, we ensure our compliance with regulatory requirements and meet customer requirements throughout the life cycle of each product. Every employee is committed to compliance with the standard.