{"id":2925,"date":"2020-06-09T13:28:53","date_gmt":"2020-06-09T11:28:53","guid":{"rendered":"https:\/\/borgensgaard-consulting.dk\/?page_id=2925"},"modified":"2020-09-18T14:50:17","modified_gmt":"2020-09-18T12:50:17","slug":"online-kursus-eu-medical-device-regulation-for-erhvervsdrivende","status":"publish","type":"page","link":"https:\/\/borgensgaard-consulting.dk\/da\/services\/online-kurser-medicinsk-udstyr\/online-kursus-eu-medical-device-regulation-for-erhvervsdrivende\/","title":{"rendered":"Online Kursus: EU Medical Device Regulation for Erhvervsdrivende"},"content":{"rendered":"
\n
\n\t

Online Course - EUs forordning om medicinsk udstyr for erhvervsdrivende<\/h2>\n

Der er gennemf\u00f8rt en grundl\u00e6ggende revision af direktivet for medicinsk udstyr 93\/42\/EEC\u00a0 for at f\u00e5 et mere robust, gennemsigtigt, forudsigeligt og b\u00e6redygtigt regels\u00e6t for medicinsk
\nudstyr, som sikrer et h\u00f8jt sikkerheds- og sundhedsniveau. Den nye forordning for medicinsk udstyr (Medical Device Regulation 745\/2017) har \u00f8get forpligtelserne for alle erhvervsdrivende: fabrikant, autoriserede repr\u00e6sentant, import\u00f8r og distribut\u00f8r.<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div>

\n\t\t\t\n\t\t\n\t\t\t\n\t\t\tK\u00f8b kursus p\u00e5 engelsk til 1 person for 1.485 kr \t\t<\/span>\n\t\t\t<\/a>\n\t<\/div>\n<\/div><\/div><\/div>
\n\t\t\t\n\t\t\n\t\t\t\n\t\t\tK\u00f8b r\u00e5dgivning og kursus for 6 personer for 9.995 kr \t\t<\/span>\n\t\t\t<\/a>\n\t<\/div>\n<\/div><\/div><\/div><\/div>
\n
\n\t

<\/h3>\n

Hvorfor du skal tage dette kursus<\/h3>\n
    \n
  • For at l\u00e6re om hvorn\u00e5r et udstyr betragtes som et medicinsk udstyr samt hvordan man opn\u00e5r overensstemmelse med forordningen<\/li>\n
  • For at f\u00e5 et overblik over dine forpligtelser som fabrikant af medicinsk udstyr til det europ\u00e6iske marked<\/li>\n
  • For at blive opm\u00e6rksom p\u00e5 dine forpligtelser n\u00e5r du importerer medicinsk udstyr til det europ\u00e6iske marked<\/li>\n
  • For at kende dine forpligtelser n\u00e5r du distribuere medicinsk udstyr p\u00e5 det europ\u00e6iske marked<\/li>\n
  • For at f\u00e5 et bevis p\u00e5 dine nye kompetencer<\/li>\n<\/ul>\n

    Hvad du vil l\u00e6re<\/h3>\n

    Du vil l\u00e6re om det lovm\u00e6ssige landskab og hvorn\u00e5r et udstyr betragtes som et medicinsk udstyr.<\/p>\n

    Du vil l\u00e6re om hvilke forpligtelser, som de forskellige erhvervsdrivende har i forhold til forordningen om medicinsk udstyr (medical device regulation 745\/2017). Selvom din virksomhed ikke er fabrikant, er der vigtig og brugbar information i disse dele af kurset, som kan hj\u00e6lpe dig til at forst\u00e5 din virksomheds forpligtelser.<\/p>\n

    Kurset er opdelt i 4 dele:<\/p>\n

      \n
    1. Introduktion til forordningen<\/li>\n
    2. Fabrikantens forpligtelser - 1<\/li>\n
    3. Fabrikantens forpligtelser - 2<\/li>\n
    4. Autoriseret Repr\u00e6sentants, Import\u00f8rs og Distribut\u00f8rs forpligtelser<\/li>\n<\/ol>\n

      Hvem skal deltage<\/h3>\n

      Enhver som gerne vil l\u00e6re om forordningen for medicinsk udstyr (medical device regulation 745\/2017) og hvilke forpligtelser man har som fabrikant, autoriseret repr\u00e6sentant, import\u00f8r samt distribut\u00f8r.<\/p>\n

      Behov for forudg\u00e5ende viden\/erfaring<\/h3>\n

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

      Format<\/h3>\n

      Dansk eller Engelsk<\/p>\n

      E-l\u00e6ring ved brug af computer eller tablet med h\u00f8jtaler i.<\/p>\n

      Online test hvor du f\u00e5r kursusbevis hvis du har minimum 80% rigtige svar.<\/p>\n

      Kursets varighed<\/h3>\n

      1 time og 40 minuter eksklusiv test<\/p>\n

      Din underviser<\/h3>\n

      Charlotte Borgensgaard<\/p>\n

      Tilg\u00e6ngelighed<\/h3>\n

      Du kan tage kurset n\u00e5r det passer dig indenfor en 3 m\u00e5neders periode, som starter ved modtagelsen af din bruger-id og kodeord.<\/p>\n

      Slides kan downloades indenfor samme periode.<\/p>\n<\/div>\n<\/div><\/div><\/div>

      \n
      \n\t

      <\/h3>\n

      Hvad f\u00e5r I ved k\u00f8b af denne ydelse<\/h3>\n
        \n
      • Dette online kursus\u00a0 for op til 6 personer inklusiv kursusbevis<\/li>\n
      • Online m\u00f8de p\u00e5 op til 3 timer inklusiv afholdelse af kurset<\/li>\n
      • Der vil v\u00e6re 1 - 1 1\/2 time til sp\u00f8rgsm\u00e5l med udgangspunkt i jeres virksomhed og specifikke behov<\/li>\n
      • Et telefonisk form\u00f8de p\u00e5 15-20 minutter<\/li>\n
      • Mulighed for at v\u00e6lge sprog tale\/pr\u00e6sentation: dansk\/dansk, dansk\/engelsk, engelsk\/engelsk<\/li>\n
      • Hands-out: dansk eller engelsk<\/li>\n<\/ul>\n

        <\/h3>\n

        <\/h3>\n

        Hvem har gl\u00e6de af denne ydelse<\/h3>\n
          \n
        • Import\u00f8rer af medicinsk udstyr<\/li>\n
        • Distribut\u00f8rer af medicinsk udstyr<\/li>\n
        • Start-up virksomheder<\/li>\n
        • Virksomheder som er nye indenfor medicinsk udstyr<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><\/div><\/div>
          \n\t\t\t\n\t\t\n\t\t\t\n\t\t\tK\u00f8b kursus p\u00e5 engelsk til 1 person for 1.485 kr \t\t<\/span>\n\t\t\t<\/a>\n\t<\/div>\n<\/div><\/div><\/div>
          \n\t\t\t\n\t\t\n\t\t\t\n\t\t\tK\u00f8b r\u00e5dgivning og kursus for 6 personer for 9.995 kr \t\t<\/span>\n\t\t\t<\/a>\n\t<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"

          Online Course – EUs forordning om medicinsk udstyr for erhvervsdrivende Der er gennemf\u00f8rt en grundl\u00e6ggende revision af direktivet for medicinsk […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":2729,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"class_list":["post-2925","page","type-page","status-publish","hentry"],"yoast_head":"\nOnline Kursus: EU Medical Device Regulation for Erhvervsdrivende - Borgensgaard Consulting<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/borgensgaard-consulting.dk\/da\/services\/online-kurser-medicinsk-udstyr\/online-kursus-eu-medical-device-regulation-for-erhvervsdrivende\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Online Kursus: EU Medical Device Regulation for Erhvervsdrivende - 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