08/06/2021

A product has been successfully approved and is on the market. Can cybersecurity activities now be discontinued? Of course, that's not possible. Cybersecurity risks arise continuously, and it's impossible to identify all vulnerabilities in advance. ...

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Medical devices have special requirements regarding usability. This is because incorrect use of medical devices can result in harm to patients or operators. To prevent this, IEC 62366-1 defines clear processes for the usability of medical devices. The standard applies ...

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05/26/2021

Over 2000 years ago, Ovid wrote, "What lasts long, finally turns out well." Sometimes it's also said, "Good things take time." And then there's the quote, "Everything has an end, only a sausage has two.". ...

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Anyone seeking approval for a medical device in the United States cannot avoid the Food and Drug Administration (FDA). Medical devices are becoming increasingly interconnected and are collecting more and more data. ...

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09/27/2020

ⓘ This event has already ended. The VDI Working Group Systems Engineering is hosting its third webinar this year. Following the last topic on FMEA and thus also on functional safety, this event focuses on Functional Safety. ...

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During one of my recent training sessions on requirements engineering, a hardware developer demonstrated in a homework assignment that he understood the topic and was able to write requirements. I found his requirements to be so well-written that..., ...

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