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 ...
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. ...
07/19/2021
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 ...
06/16/2021
References: When IEC 62304 or ISO 14971 is mentioned below, the following editions are meant: IEC 62304:2006 + A1:2015 and EN ISO 14971:2012 Problem: We are developing software/firmware that is a component of a medical device. The software (or the ...
Update Notice (May 23, 2025) This article is based on AAMI TIR57:2016, an important guideline for cybersecurity risk management in medical devices. Since 2023, TIR57 has been supplemented by the new standard ANSI/AAMI SW96:2023, which formalizes the content and ...
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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