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quality certification |
Quality certification
DEAS EN/ISO 9001 Certificate
| DEAS EN/ISO 13485 Certificate
DEAS maintains a quality system in the manufacturing process which ensures
conformity with the type described in the technical documentation.
DEAS CE Mark
Within
the European Union, EU, conformity of products and the proper application
of the CE marking to medical devices is necessary for marketing. The intent
is to ensure compliance with all relevant EU Directives.
Background
The guarantee of free trade of goods within the Community is the most important
objective. This will eliminate trade restrictions that result from different
technical regulations in each individual member country. Harmonization of
existing European standards and regulations, is being accomplished and already
partially realized. Based on this goal, a new concept for creating directives
was formed in 1985 by the European Community (EC) Commission to produce
directives with a wide range of application which contain only the most
basic safety requirements.
The CE Mark
The CE mark is prescribed by law and assures the European free trade of
goods. It is short for ”Communauté Européen”,
and is displayed on goods and/or packaging which acts as an external symbol
for the inspection of products. It also illustrates the manufacturer’s
responsibility to uphold the community’s directives.
DEAS' commitment to the directives
DEAS will attach the CE mark in accordance with the product directives.
Our products will conform as follows:
- Declarations of conformity for DEAS products will be available when required by the relevant EU directives.
- Those products required to do so will bear CE marking as specified by the relevant EU directives and CE marking regulations.
- Necessary technical documentation will be on file and made available to authorized organizations upon written request.
