Our quality policy : a daily commitment

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Laboratoire Sylamed activity needs great requirement about its products quality. Its customers and users rely on its checking processes.

The whole manufacturing process from the design, the arrival of raw material, to the final product is subject to strict controls.

Thus, Laboratoire Sylamed is certified ISO 9001: 2008 and ISO 13485:2012 (quality management system approval) by LNE/G-MED and all products we sell carry the CE mark and comply the European Directive 93/42/EEC.

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The sterilization process used is audited and validated according to ISO 11135 or ISO 11137.

The control of the initial contamination of these products is ensured by the quality control done at each manufacturing level.
Quality follow-up is entirely ensured by a team led by a quality manager pharmacist.

 

Our certificates

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EC certificate - class I

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EC certificate - class IIa

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ISO 9001 2008

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ISO 13485 2012

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Legal information

According to the European Directive 93/42/CEE, our products sold are only for single-use, and their reuse can cause some infections.