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 guidance on this. ...
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 ...
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