European authorised representative

Comply with local requirements and regulations of various european markets

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CE marking

Meet the requirements of the European CE marking process

Details

Authorities & notified bodies

Contact with authorities & notified bodies during the whole marketing process

Details

Product development

Test your product before entering the market

Details

Technical file constructions & review

Get your technical documentation right

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Essential requirements

Make sure your dossier contains all essential requirements

Details

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)

Details

SOPs

Formulate procedures to assure control of production and processes

Details

Due diligence

Review your information

Details
SOP templates
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