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Quality assurance and environmental management
Quality assurance for
the user and patient.
Dentaurum Implants can look back on more than 20 years
of experience in implantology while the parent company
Dentaurum has 130 years of experience in prosthetics. This
solid foundation ensures that development is based on a
wealth of experience with the focus on the user and highquality
production of the tioLogic® implant system.
In all its business activities Dentaurum Implants GmbH, like
the parent company Dentaurum GmbH & Co. KG, meets
the requirements of the international quality management
standards.
Norms:
DIN EN ISO 9001:2000
Quality Management Systems
DIN EN ISO 13485 Medical Devices
Quality Management Systems
The term “quality management” covers systematic planning,
implementation and documentation of all activities that have
an influence on the quality of a product before, during and
after its manufacture. The focus is not therefore solely on
the final inspection of a product but on continuous quality
control during development of the product, from the raw
material to manufacture right through to storage and sale.
The above standards define in detail the criteria for ensuring
comprehensive quality assurance by a company for all its
operating procedures.
Based on this quality management system Dentaurum Implants
guarantees traceability and that the quality of the products
and services will meet the expectations of the customers and
patients. The products fulfill the fundamental requirements
of medical products in terms of product performance and
patient safety as defined in European laws and directives. As
the respective products of Dentaurum Implants GmbH meet
the requirements of the European Directive 93/42/EEC for
medical products, they carry the CE mark.