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Worldwide approvals
We also design, develop and manufacture medical products for target markets outside of Europe. The specific requirements for these markets are considered during product development. You benefit from our experience and contacts, for example for medical product approvals for the US market. Our quality assurance system was developed to conform to ISO 9001:2008, ISO 13485:2007 and QSR-21CFR820 (FDA) regulations. This allows us to provide the development and manufacturing of products, especially medical devices, for the world market.
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ISO 9001:2008
certification
ISO 13485:2007