{"id":3198,"date":"2021-03-03T10:46:34","date_gmt":"2021-03-03T09:46:34","guid":{"rendered":"https:\/\/borgensgaard-consulting.dk\/?page_id=3198"},"modified":"2021-04-21T15:02:35","modified_gmt":"2021-04-21T13:02:35","slug":"online-kursus-importoer-og-distributoer-af-medicinsk-udstyr-paa-det-europaeiske-marked","status":"publish","type":"page","link":"https:\/\/borgensgaard-consulting.dk\/da\/online-kursus-importoer-og-distributoer-af-medicinsk-udstyr-paa-det-europaeiske-marked\/","title":{"rendered":"Online Kursus – Import\u00f8rer og Distribut\u00f8rer af Medicinsk Udstyr p\u00e5 det Europ\u00e6iske Marked"},"content":{"rendered":"
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Online Kursus for Import\u00f8rer og Distribut\u00f8rer af Medicinsk Udstyr<\/strong><\/h1>\n

EUs forordning om medicinsk udstyr (745\/2017)\u00a0<\/strong><\/h1>\n<\/div>\n<\/div><\/div>
\n\t\t\t\n\t\t\n\t\t\t\n\t\t\tBook din plads nu\t\t<\/span>\n\t\t\t<\/a>\n\t<\/div>\n<\/div><\/div>
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Dato: 26. maj 2021 kl. 9.00 \u2013 12.00\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Pris: 2.250 DKR ex moms<\/h2>\n

Tilmelding senest 11. maj<\/em><\/h3>\n

Der er gennemf\u00f8rt en grundl\u00e6ggende revision af direktivet for medicinsk udstyr (93\/42\/EEC) for at f\u00e5 et mere robust regels\u00e6t. Det har resulteret i en ny forordning for medicinsk udstyr (Medical Device Regulation 745\/2017), hvor der er \u00f8get forpligtelserne for import\u00f8rer og distribut\u00f8rer af medicinsk udstyr til det det Europ\u00e6iske marked.<\/p>\n

Hvorfor du skal tage dette kursus<\/strong><\/h2>\n
    \n
  • Hvis du er i tvivl om, hvorn\u00e5r man er import\u00f8r og hvorn\u00e5r man er distribut\u00f8r ifht. regulativet.<\/li>\n
  • Hvis du gerne vil have en bedre forst\u00e5else af, hvad som st\u00e5r i regulativet, og hvad som forventes af en import\u00f8r og distribut\u00f8r af medicinsk udstyr.<\/li>\n
  • Hvis du gerne vil have en bedre forst\u00e5else af forskellen i forpligtelserne for en import\u00f8r og distribut\u00f8r.<\/li>\n
  • Hvis du gerne vil have input til, hvordan du sikrer at du overholder dine forpligtelser samt undg\u00e5r faldgrupper.<\/li>\n<\/ul>\n

    Hvad du vil l\u00e6re p\u00e5 dette kursus<\/strong><\/h2>\n
      \n
    • Du vil f\u00e5 et overblik over det lovm\u00e6ssige landskab<\/li>\n
    • Du vil l\u00e6re hvorn\u00e5r et udstyr betragtes som et medicinsk udstyr<\/li>\n
    • Du vil forst\u00e5 indholdet af EC overensstemmelseserkl\u00e6ring (EC declaration of conformity)<\/li>\n
    • Du vil forst\u00e5 din rolle(r) ifht. det medicinske regulativ<\/li>\n
    • Du vil forst\u00e5 dine forpligtelser som import\u00f8r og\/eller distribut\u00f8r af medicinsk udstyr<\/li>\n
    • Du vil f\u00e5 overblik over overgangsregler og tidsfrister<\/li>\n
    • Du vil l\u00e6re om UDI (Unique Device Identification)<\/li>\n
    • Du vil f\u00e5 vist et eksempel p\u00e5 opbygning af et kvalitetsstyringssystem<\/li>\n<\/ul>\n

      \u00a0<\/strong>Hvem skal deltage<\/strong><\/h2>\n

      Enhver som arbejder med import eller distribution af medicinsk udstyr til det Europ\u00e6iske marked.<\/p>\n

      Behov for forudg\u00e5ende viden\/erfaring<\/strong><\/h2>\n

      Du beh\u00f8ver ikke at have viden\/erfaring indenfor omr\u00e5det for at deltage i kurset.<\/p>\n

      Format<\/strong><\/h2>\n

      Pr\u00e6sentationsmateriale vil v\u00e6re p\u00e5 dansk og undervisningen vil ligeledes foreg\u00e5 p\u00e5 dansk.
      \nE-l\u00e6ring ved brug af computer eller tablet med h\u00f8jtaler og mikrofon.<\/p>\n

      Kursets varighed<\/strong><\/h2>\n

      Ca. 3 timer<\/p>\n

      Underviser<\/h2>\n

      Charlotte Borgensgaard<\/p>\n

      Antal Deltagere<\/strong><\/h2>\n

      Maksimum 20 deltagere s\u00e5ledes at der er tid nok til sp\u00f8rgsm\u00e5l.<\/p>\n<\/div>\n<\/div><\/div>

      \n\t\t\t\n\t\t\n\t\t\t\n\t\t\tBook din plads nu\t\t<\/span>\n\t\t\t<\/a>\n\t<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"

      Online Kursus for Import\u00f8rer og Distribut\u00f8rer af Medicinsk Udstyr EUs forordning om medicinsk udstyr (745\/2017)\u00a0 Dato: 26. maj 2021 kl. 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