1 Surgery CAMLOG Compendium

Information
Certificate
Quality for Users and Patients
ALTATEC GmbH is in all stages of its activities subject to the
provisions set out by the Quality Protection System according to
EN ISO 13485:2003.
This European Standard defines in detail the criteria that have to
be met by full quality protection of a company in all its processes
in order for this company to be certified. Medical products have
to adhere to standards that are parti-cularly demanding.They are
defined in the European Standard ISO 13485,which we are also
able to satisfy.
We thereby ensure that the quality of our products and services
meets the expectations of our customers,namely in a manner that
is at all times monitored and retraceable.Our products fulfil the
requirements for medical products in terms of product performance
and patient safety,as they have been defined by the
European Laws and Standards.Thus,all our legally controlled
products carry the CE label.
The products are in accordance with the strict requirements of
the European Medical Device Directive 93/42/EEC for medical
products and the Standards EN ISO 13485:2003.
159