Quality is a 'NEVER-ENDING STORY'

The most important factor for the quality of Helmut Zepf is that a 100% quality is feasible.

Helmut Zepf Medizintechnik GmbH operates a quality management system certified according to EN ISO 13485 + EU directive. Our risk management system focuses on ISO 14971 in line with the conditions of the Medical Product Directive (MPG).
In addition we implement international guidlines in our quality management program like the the guidlines of the American Food and Drug Administration (FDA). 

Our quality is the standard for our plan for success

Quality is the first priority in our daily actions and is the link between the individual production steps. Starting with the technical feasibility throuogh a high degree of vertical integration up to the marketing of our product range - quality is a reoccuring theme in our company. Not least because of our experience in the production of medical devices since 1921.

Our quality management ensures that every product leaving our company has to undergo a 100% quality control - beginning with the production and ending with the shipment. Deviations or complaints are followed up, documented and corrected immediately. A pro-active handling of failures is leading to an active prevention of complaints. However, this only works where there is trust between the management, head of department and employees.
 

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