Insight
Cybersecurity in Medical Devices
Can a hacked medical device be dangerous?
- 24 October 2025
- 3 min
The integration of cybersecurity measures in medical devices is critical to ensuring patient safety and maintaining the integrity of healthcare systems. In this whitepaper you will find a clear approach to comply to medical regulations with respect to cybersecurity requirements.
Whitepaper Cybersecurity in medical devices
This whitepaper explores the key considerations outlined in the FDA’s “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” and the European MDCG 2019-16 Rev.1 guidance on cybersecurity for medical devices.
It will also give a short overview on current guidances addressing cybersecurity for medical devices in both the US and EU. Next we will highlight our quality management and development considerations for manufacturers based on both guidance’s.
The paper will end with how we can support you with our many years of experience in medical software development and cybersecurity.
Download whitepaper
Download the whitepaper: Cybersecurity in Medical Devices.
Cybersecurity in Medical Devices
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