CASE STUDY (C)


    Client-Partner             -     early stage start-up company

    Product                     -     delivery system for therapeutic agents to the myocardium

    Project                      -     CE Marking of the device prior to the approval of the client-partner's
                                          combination product

    Number of Sites          -     not applicable

    Countries                   -     not applicable

    Psephos services         -     negotiations with relevant Notified Bodies
                                    -     establishing clinical safety data requirements
                                    -     input to overall product development strategy





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clinical research, regulatory support and new technology