Technical information Quality system
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 high-quality production of the tioLogic®
implant system.
In all its business activities Dentaurum Implants
GmbH, like the parent company Dentaurum,
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 infl uence on the
quality of a product before, during and after its
manufacture. The focus is not therefore solely
on the fi nal 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 defi ne 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 fulfi ll the fundamental
requirements of medical products in terms of
product performance and patient safety as
defi ned 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.
Quality Assurance
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