Quality is our core principle
The objective of our efforts is to develop, manufacture and market products that benefit the patient, fulfill customer requirements and ensure the satisfaction and trust of the consumer.
Our quality management system contributes to our achievement of this goal. It covers the entire product life cycle from product idea and development to production and use by patients.
The brand name Löwenstein Medical is the promise of high-quality and safe products with great benefit for patients. We set high standards for our products and services and meet them through strict adherence to our quality policy.
Löwenstein Medical quality management is based on the standard DIN EN ISO 13485. The Notified Body TÜV Rheinland conducts regular audits and provides a neutral and independent assessment of our conformance with requirements.
When we comply with the requirements of our own quality management system, we also conform to national and international laws and directives. Among them are the German Medical Devices Act (MPG), the European Medical Device Directive 93/42/EEC and the Quality Management requirements 21CFR820 of the U.S. Food and Drug Administration.
Quality leader in international competition. . .
. . . is the goal of Löwenstein Medical’s quality management system. We achieve that goal through the continuous improvement of our products and services and with the commitment of our employees and their ongoing development.
We consistently deliver on our promise by meeting high quality standards for all processes in research and development, purchasing, production, quality management and, of course, in our products.
Director of Quality Management and Regulatory Affairs