{"id":661,"date":"2019-10-05T23:04:54","date_gmt":"2019-10-05T21:04:54","guid":{"rendered":"https:\/\/borgensgaard-consulting.dk\/?page_id=661"},"modified":"2026-09-04T10:29:42","modified_gmt":"2026-09-04T08:29:42","slug":"regulativer-og-standarder","status":"publish","type":"page","link":"https:\/\/borgensgaard-consulting.dk\/da\/regulativer-og-standarder\/","title":{"rendered":"Compliance"},"content":{"rendered":"
\n
\n\t\t\"Regulativer\n\t<\/div>\n\n<\/div><\/div><\/div><\/div>
\n
\n\t

Compliance<\/h1>\n

Jeg hj\u00e6lper virksomheder med at forst\u00e5, implementere og vedligeholde compliance med g\u00e6ldende regulatoriske krav og kvalitetskrav inden for medicinsk udstyr, IVD og prim\u00e6r farmaceutisk emballage.
\nMin erfaring omfatter b\u00e5de fortolkning af krav og praktisk implementering p\u00e5 tv\u00e6rs af Quality, R&D og Operations.<\/p>\n

Omr\u00e5der, jeg kan hj\u00e6lpe med<\/h2>\n

Jeg kan blandt andet hj\u00e6lpe virksomheder med:<\/p>\n

    \n
  • MDR- og IVDR-compliance<\/li>\n
  • Regulatoriske gap-analyser<\/li>\n
  • Implementering af nye eller \u00e6ndrede krav<\/li>\n
  • Teknisk dokumentation<\/li>\n
  • Compliance-aktiviteter relateret til Design Control<\/li>\n
  • Krav til kvalitetsledelsessystemer<\/li>\n
  • Krav til import\u00f8rer, distribut\u00f8rer og andre \u00f8konomiske akt\u00f8rer<\/li>\n
  • Produktklassificering og regulatoriske vurderinger<\/li>\n
  • Implementering og forbedring af compliance-processer<\/li>\n
  • Tr\u00e6ning og vidensoverf\u00f8rsel<\/li>\n<\/ul>\n

    Medicinsk udstyr og IVD<\/h2>\n

    En v\u00e6sentlig del af mit konsulentarbejde har omfattet implementering og fortolkning af krav relateret til EU-forordningen om medicinsk udstyr (MDR) og EU-forordningen om in vitro-diagnostisk medicinsk udstyr (IVDR).
    \nMin erfaring omfatter st\u00f8tte til virksomheder med vurdering af g\u00e6ldende krav, gap-analyser, implementeringsaktiviteter samt udarbejdelse og forbedring af den dokumentation, der kr\u00e6ves for at demonstrere compliance.<\/p>\n

    Prim\u00e6r farmaceutisk emballage<\/h2>\n

    Min baggrund omfatter desuden 16 \u00e5rs erfaring inden for prim\u00e6r farmaceutisk emballage, hvor jeg arbejdede med Quality- og Regulatory-krav i et internationalt produktionsmilj\u00f8.\u00a0Dette omfatter erfaring med ISO 15378, GMP-relaterede krav og regulatoriske krav, der g\u00e6lder for prim\u00e6r emballage til l\u00e6gemidler.<\/p>\n

    Regulatoriske krav og kvalitetsstandarder<\/h2>\n

    Min erfaring omfatter arbejde med krav relateret til:<\/p>\n

      \n
    • MDR<\/li>\n
    • IVDR<\/li>\n
    • ISO 13485<\/li>\n
    • ISO 14971<\/li>\n
    • ISO 15378<\/li>\n
    • MDSAP<\/li>\n
    • Andre relevante regulatoriske krav og kvalitetskrav<\/li>\n<\/ul>\n

      Praktisk implementering<\/h2>\n

      Compliance handler ikke kun om at forst\u00e5 kravene. Det handler ogs\u00e5 om at oms\u00e6tte dem til processer, dokumentation og arbejdsgange, der kan implementeres effektivt i organisationen.
      \nMin tilgang er pragmatisk og proportionel med fokus p\u00e5 at sikre compliance uden un\u00f8dvendig kompleksitet.
      \nHvis du \u00f8nsker at dr\u00f8fte en compliance-udfordring eller en potentiel opgave, er du meget velkommen til at kontakte mig.<\/p>\n

      <\/div>\n

      <\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"

      Compliance Jeg hj\u00e6lper virksomheder med at forst\u00e5, implementere og vedligeholde compliance med g\u00e6ldende regulatoriske krav og kvalitetskrav inden for medicinsk […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"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-661","page","type-page","status-publish","hentry"],"yoast_head":"\nCompliance - 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\/regulativer-og-standarder\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Compliance - 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