Hardware & Making
Warum die Card10 kein Medizinprodukt ist
Was müssen Medizinproduktehersteller einhalten (und was nicht)?
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 |
More sessions
| 12/27/19 |
While open source is necessary for trustable hardware, it is far from sufficient. This is because “hashing” hardware – verifying its construction down to the transistor level – is typically a destructive process, so trust in hardware is a massive time-of-check/time-of-use (TOCTOU) problem. This talk helps us understand the nature of the TOCTOU problem by providing a brief overview of the supply chain security problem and various classes of hardware implants. We then shift gears to talk ...
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| 12/27/19 |
This talk will cover everything about the Acorn Archimedes, a British computer first released in 1987 and (slightly) famous for being the genesis of the original ARM processor.
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| 12/27/19 |
Modern smartphones offer a whole range of sensors like magnetometers, accelerometers or gyroscopes. The open source app "phyphox", developed at the RWTH Aachen University, repurposes these sensors as measuring instruments in physics education.
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| 12/27/19 |
(en) We make Standard Cells for LibreSilicon available, which are open source and feasible. And we like to talk and demonstrate what we are doing. (de) Wir machen Standardzellen für LibreSilicon verfügbar, welche Open Source und nutzbar sind. Wir möchten darüber sprechen und vorführen, was wir tun.
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| 12/27/19 |
Billions of subscribers use SIM cards in their phones. Yet, outside a relatively small circle, information about SIM card technology is not widely known. This talk aims to be an in-depth technical overview.
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| 12/28/19 |
There's a variety of places - on Earth and beyond - that pose challenging conditions to the ever-shrinking digital circuits of today. Making those tiny transistors work reliably when bombarded with charged particles in the vacuum of space, in the underground tunnels of CERN or in your local hospital's X-ray machine is not an easy feat. This talk is going to shed some light on what can be done to keep particles from messing up your ones and zeroes, how errors in digital circuits can be detected ...
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| 12/28/19 |
Most modern embedded devices have something to protect: Whether it's cryptographic keys for your bitcoins, the password to your WiFi, or the integrity of the engine-control unit code for your car. To protect these devices, vendors often utilise the latest processors with the newest security features: From read-out protections, crypto storage, secure-boot up to TrustZone-M on the latest ARM processors. In this talk, we break these features: We show how it is possible to bypass the security ...
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