Where is that headset now? Who hasn't experienced this: you want to connect your smartphone to a Bluetooth device, start the search process, and suddenly you can't see the forest for the trees, er... available clients. ...
10/31/2022
In medical technology, technical errors in a device can have fatal consequences for operators or patients. Therefore, a safety architecture is generally required during the approval process for medical devices. It is important to consider the issue of functional safety right from the design stage. ...
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. ...
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 ...
03/15/2021
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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