International legal representative
Authorised legal representative of medical device is a legal person in most markets who in behalf of legal manufacturer to register medical device to authority. It is also called legal agent, responsible person, marketing authorised holder or sponsor.
We can be legal representative over the worldwide market of medical device.
We know
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How to get medical device approved
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How to transfer country specific regulations
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How to avoid non-conformity by coordinating with your distributor
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How to communicate fast and conform in case of vigilance
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How to bring labelling in different language with info of legal representative
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Technical documentation
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Quality management
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Post market surveillance
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Supply chain
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Tender
We have
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Process of legal presentative service
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Local experts speaking regulatory- and country language
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Record approval quote of medical device
Besides it, we can offer
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Inspecting your legal representative upon local requirements plus your in-house supplier management
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Controlling your legal representative in our KPI-workshops or e-learning of regulatory affairs
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Customer tailored template in terms of working with international partner (change notification and vigilance form)
Our professional workflow of International legal representative
