12/30/2021

Got plans for next year? We're looking for software developers for embedded systems in medical technology. If you're interested in medicine and have software experience, we'd love to have you join us next year! ...

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11/29/2021

1, 2 or 3 is not only the question in a well-known quiz show for children on public television, but also for companies that want to market a medical device in the EU. The MDR provides in Article ...

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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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