Producing products of the highest and consistent quality is one of our top goals in our company. The Medical Handles made by us are manufactured in accordance with the strict requirements of MDR Regulation (EU) 2017/745 (Class I) and EU Directive 93/42 EEC and additionally bear the CE mark.
In order to maintain this targeted quality, we operate a quality management system that complies with the provisions of DIN EN ISO 9001: 2015 for quality management systems and the IATF 16949: 2016. Through a careful quality management system, we ensure optimal safety and the long-lasting, flawless functionality of our products.
Regular audits ensure the maintenance of the certification and the consistent quality. In addition, all handles are subjected to a comprehensive risk analysis and evaluation as part of risk management in accordance with DIN EN 14971. The safety and protection of patients is an important feature of our medical handholds.
Quality Control
An essential part of our quality management is quality assurance, which is responsible for ensuring that all our products leave the company in perfect condition. In order to guarantee this, regular random samples are taken during production and incoming and outgoing inspections are carried out.
In order to ensure the safety of our handles, random samples are subjected to optical and substantial tests in our internal testing laboratory. The most modern measuring equipment is available for the tests, which are subject to test equipment monitoring in accordance with DIN EN ISO 9001: 2015. This includes regular calibration and maintenance by an accredited testing laboratory.
In addition, we perform regular, process-accompanying load tests (Tensile tests) and endurance tests. These tests are performed on the individual components as well as on fully assembled medical handles.
All test and test results are documented, evaluated and can be retrieved at any time.
