camlog® prosthetics

CAMLOG ® IMPLANTATSYSTEM
INFORMATION
CERTIFICATE
Quality for users and patients
ALTATEC GmbH as the manufacturer of the CAMLOG ®
products 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 particularly
demanding. They are defined in the European
Standard ISO 13485, which we are also able to satisfy.
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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 of the ALTATEC GmbH 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