{"guid":"d274ccf9-c5ed-4b88-a641-7ca8d5b4cedc","title":"Warum die Card10 kein Medizinprodukt ist","subtitle":"Was müssen Medizinproduktehersteller einhalten (und was nicht)?","slug":"36c3-10950-warum_die_card10_kein_medizinprodukt_ist","link":"https://fahrplan.events.ccc.de/congress/2019/Fahrplan/events/10950.html","description":"\u003cp\u003eEs soll grundlegend erkl\u0026auml;rt werden, nach welchen Kriterien Medizinprodukte entwickelt werden. Dazu werden die wichtigsten Regularien (Gesetze, Normen, ...) vorgestellt die von den Medizinprodukteherstellern eingehalten werden m\u0026uuml;ssen. Diese regeln, was die Hersteller umsetzen m\u0026uuml;ssen (und was nicht). Hier wird auch die Frage beantwortet, warum beispielsweise die Apple-Watch (oder genauer gesagt nur zwei Apps) ein Medizinprodukt sind aber die card10 nicht. Dieser Vortrag gibt Antworten auf die folgenden Fragen:\u003c/p\u003e\r\n\u003cul\u003e\r\n\u003cli\u003eWas ist denn \u0026uuml;berhaupt ein Medizinprodukt?\u003c/li\u003e\r\n\u003cli\u003eWas steht dazu im Gesetz?\u003c/li\u003e\r\n\u003cli\u003eWas haben Normen damit zu tun?\u003c/li\u003e\r\n\u003cli\u003eWas tun die Hersteller \u0026uuml;berlicherweise um diese Anforderungen umzusetzen?\u003c/li\u003e\r\n\u003cli\u003eWie sieht ein typischer Entwicklungsprozess aus?\u003c/li\u003e\r\n\u003cli\u003eWie sieht es mit Security und Safety aus?\u003c/li\u003e\r\n\u003cli\u003eWarum sind Innovationen so schwer?\u003c/li\u003e\r\n\u003cli\u003eWas passiert nach der Entwicklung?\u003c/li\u003e\r\n\u003cli\u003eWer \u0026uuml;berwacht das alles?\u003c/li\u003e\r\n\u003c/ul\u003e\r\n\u003cp\u003eEs wird Schwerpunktm\u0026auml;\u0026szlig;ig die EU betrachtet um die Dauer des Vortrags nicht zu sprengen.\u003c/p\u003e","original_language":"deu","persons":["Phil"],"tags":["36c3","10950","2019","Hardware \u0026 Making","Main"],"view_count":7296,"promoted":false,"date":"2019-12-27T22:10:00.000+01:00","release_date":"2019-12-28T01:00:00.000+01:00","updated_at":"2026-04-03T14:00:05.484+02:00","length":3750,"duration":3750,"thumb_url":"https://static.media.ccc.de/media/congress/2019/10950-hd.jpg","poster_url":"https://static.media.ccc.de/media/congress/2019/10950-hd_preview.jpg","timeline_url":"https://static.media.ccc.de/media/congress/2019/10950-hd.timeline.jpg","thumbnails_url":"https://static.media.ccc.de/media/congress/2019/10950-hd.thumbnails.vtt","frontend_link":"https://media.ccc.de/v/36c3-10950-warum_die_card10_kein_medizinprodukt_ist","url":"https://api.media.ccc.de/public/events/d274ccf9-c5ed-4b88-a641-7ca8d5b4cedc","conference_title":"36C3: Resource 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