{"id":17056,"date":"2025-08-29T10:43:40","date_gmt":"2025-08-29T08:43:40","guid":{"rendered":"https:\/\/www.thema-med.com\/academy\/?page_id=17056"},"modified":"2025-09-11T09:02:59","modified_gmt":"2025-09-11T07:02:59","slug":"post-market-surveillance-under-mdr-il-punto-di-vista-dellente-notificato","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/academy\/post-market-surveillance-under-mdr-il-punto-di-vista-dellente-notificato\/","title":{"rendered":"Post Market Surveillance under MDR: il punto di vista dell\u2019Ente Notificato"},"content":{"rendered":"

  • <\/i><\/span>
    18\/09\/2025<\/div><\/li><\/ul>

    Post Market Surveillance under MDR: il punto di vista dell\u2019Ente Notificato<\/span><\/h1><\/h1><\/div>

    Il webinar approfondir\u00e0 la Post Market Surveillance (PMS) partendo dai requisiti necessari per essere conformi a MDR.<\/span><\/p>\n

    Analizzeremo quali sono le attivit\u00e0 pi\u00f9 importanti in carico dei fabbricanti, quali sono le aspettative di un organismo notificato come BSI in un PMS Plan e come strumenti quali la \u201cinteractive dedicated review\u201d consentono di interagire potendo scambiare chiarimenti sulle aspettative dell\u2019Ente Notificato.<\/span><\/p>\n

    Andremo ad affrontare argomenti quali Periodic Safety Update Report, Summary of Safety and Clinical Performance, fino ad arrivare alle attivit\u00e0 di Post Market Clinical Follow up focalizzandoci anche sulla raccolta di dati clinici e\/o clinical studies ai sensi del Regolamento MDR.<\/p>\n

    Attraverso questa sessione con molti riferimenti al regolamento e alle linee guida, i fabbricanti potranno acquisire una conoscenza approfondita, utile per la preparazione di una corretta documentazione tecnica.<\/p>\n<\/div><\/div><\/div>

    <\/span><\/div><\/div><\/div><\/div><\/div>

    Iscrizioni chiuse<\/h2>\n<\/div><\/div><\/div><\/div><\/div>
    <\/i><\/div><\/div>

    Modalit\u00e0<\/strong><\/p>\n

    Live Streaming<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>

    <\/i><\/div><\/div>

    Data<\/strong><\/p>\n<\/div>

    18 settembre 2025<\/p>\n<\/div>

    Orario
    \n<\/strong>h. 11:00 – 12:00<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>

    <\/i><\/div><\/div>

    A chi \u00e8 rivolto<\/strong><\/p>\n

    Fabbricanti, in particolare professionisti con ruolo di:<\/p>\n<\/div>

    • <\/i><\/span>
      \n

      PRRC \u2013 art. 15 MDR\/IVDR<\/p>\n<\/div><\/li>

    • <\/i><\/span>
      Regulatory Affairs<\/div><\/li>
    • <\/i><\/span>
      Quality Management<\/div><\/li>
    • <\/i><\/span>
      Quality Assurance<\/div><\/li>
    • <\/i><\/span>
      R&D<\/div><\/li><\/ul>

      Altri Operatori Economici (mandatari, importatori e distributori)<\/p>\n

      Consulenti<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>

      <\/i><\/div><\/div>

      Quota di partecipazione<\/strong><\/p>\n

      Gratuito<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>

      <\/i><\/div><\/div>

      Relatori<\/strong><\/p>\n

      Dott. Stefano Riva, Senior Technical Specialist & Scheme Manager – Active Devices – <\/em>BSI
      \nIng. Antonio Carciati, Project Manager & QA\/RA Consultant<\/em> – Thema<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>

      <\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-17056","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nPost Market Surveillance under MDR: il punto di vista dell\u2019Ente Notificato - Thema Academy<\/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:\/\/www.thema-med.com\/academy\/formazione-2025__trashed\/post-market-surveillance-under-mdr-il-punto-di-vista-dellente-notificato\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Post Market Surveillance under MDR: il punto di vista dell\u2019Ente Notificato - 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