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  3. ISO 13485

The application of the standard in design, production, sales, installation and technical support activities of medical devices ensures (partly) the compliance with the requirements of three EU directives for the evaluation and CE marking.

EN ISO 13485 certification gives you advantages worldwide, not just on the European market. This certification is a prerequisite for marketing your products in other international markets.

Medical device experts at TÜV NORD Korea also have extensive knowledge about current and prospective regulations affecting medical device access to the Korean market, and maintain effective communications with national regulators and representatives of international manufacturers.

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