Cybersecurity is no longer seen as an option in medical technology; it's mandatory. With IEC 81001-5-1 and the requirements of the MDR, manufacturers of medical devices and health software must proactively identify, assess, and manage security risks. A proven approach ...
12/11/2025
Cybersecurity is mandatory. EU Regulation 2017/745 (MDR) requires that medical devices be protected against unauthorized access. For manufacturers of medical devices and health software, this means they must actively address digital threats, both technically and from a regulatory perspective. IEC 81001-5-1 provides, for the first time, a standard for this purpose. ...
12/09/2025
Product variety and integration pressure: The invisible bottleneck in OP-LeuchtenSysML v2 for operating room lights is becoming increasingly important, as operating room lights are now highly complex, mechatronic medical devices with a growing variety of models. Mechanics, optics, electronics, and software must be consistently integrated – while regulatory requirements are also increasing. ...
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 ...
03/25/2021
ⓘ This event has already ended. Summary Topic: Modelling for Everyone Date: April 28, 2021, 6 p.m. to 8 p.m. Location: Online Registration deadline: April 27, 2021 Price: free I'm in Event Info The first meeting this year on the topic of Systems Engineering will take place ...
Eclipse is an open-source development environment that supports multiple programming languages. More and more microcontroller manufacturers are using the IDE to provide a free development environment with a pre-installed toolchain. Examples include STM32CubeIDE, Simplicity Studio, and others. Eclipse offers ...
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