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Our services

  • Guidance documents for CE marking

    In order to save time for our customers, we have created series of PC files to help them to build their Technical files.We give them free of charge.

  • Official European notification/registration of devices

    Since the installment of the European Databank for MD and IVD products in May 2011, we notify the French Competent Authority on a special bilingual form with English and (...)

  • Some other services

    FREE SALES CERTIFICATES

  • Operational assistance to labels

    Our customers submit us their draft of labels. We check them and propose corrections, if any, for full compliance with the Directives and EN Standards.We also provide (...)

  • Keeping, maintaining and updating your technical files

    For answering to European Competent Authorities requests in terms of European availability and product notification/registration, we request you a list of documents from your Technical file.

  • Incident analysis and incident classification

    When an incident or near incident is reported to us by the manufacturer, we conduct within 48 hours an analysis of the event versus the European Vigilance Guidelines to (...)

  • Incident reporting

    In case the Incident is reportable, we fill in, after agreement with the Manufacturer, an initial incident report according to the format given by the EU Vigilance Guidelines. (...)

  • Recall (withdrawal) notification

    When a Manufacturer decides to implement a voluntary recall, it is requested by some EU National Competent Authorities (NCAs) to review the user’s Field Safety Notice prior to (...)

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