Session
Fahrplan - Hauptprogramm 36C3
Hardware & Making

Warum die Card10 kein Medizinprodukt ist

Was müssen Medizinproduktehersteller einhalten (und was nicht)?
Dijkstra
Phil
Es soll grundlegend erklärt werden, nach welchen Kriterien Medizinprodukte entwickelt werden. Dazu werden die wichtigsten Regularien (Gesetze, Normen, ...) vorgestellt die von den Medizinprodukteherstellern eingehalten werden müssen. Diese regeln, was die Hersteller umsetzen müssen (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:

Was ist denn überhaupt ein Medizinprodukt?

Was steht dazu im Gesetz?

Was haben Normen damit zu tun?

Was tun die Hersteller überlicherweise um diese Anforderungen umzusetzen?

Wie sieht ein typischer Entwicklungsprozess aus?

Wie sieht es mit Security und Safety aus?

Warum sind Innovationen so schwer?

Was passiert nach der Entwicklung?

Wer überwacht das alles?

Es wird Schwerpunktmäßig die EU betrachtet um die Dauer des Vortrags nicht zu sprengen.

Additional information

Type lecture
Language German

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