CE marking

Meet the requirements of the European CE marking process

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Authorities & notified bodies

Contact with authorities & notified bodies during the whole marketing process

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Product development

Test your product before entering the market

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Technical file constructions & review

Get your technical documentation right

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Essential requirements

Make sure your dossier contains all essential requirements

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Product classification

Classify your devices correctly

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Artwork & labelling

Align artwork and labels with your technical file

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Regulatory intelligence / survey

Keep abreast of changes in regulations and standards

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Vigilance

An appropriate system of vigilance and Post Market Surveillance (PMS)

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SOPs

Formulate procedures to assure control of production and processes

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Due diligence

Review your information

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