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Distributors of medical devices in Europe |
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Distributors in the medical devices have to fulfil more requirements than in other sectors. Above the usual requirements you may want (knowledge of the product, implantation in the distribution network, …), they also need: - to make their part in the legal requirements (traceability, recall, information, …) - to meet guidelines concerning good Distribution Practices (required in some countries) - to register the distribution to the national Competent Authority Thanks to its network, ABR proposes to select the distributors and to perform in your name the audit in order to demonstrate that the selected distributor meet the requirements.
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