Healthcare & Medical Devices
When patient care depends on connectivity, cybersecurity becomes lifesaving
CYMETRIS enables medical-grade risk assessments per MDR, FDA & ISO 14971—protecting connected devices and sensitive health data by design.
Digital health depends on the security of every connected component
From MRI scanners and infusion pumps to cloud-connected pacemakers and health apps—medical devices are evolving into distributed, data-rich platforms. This connectivity improves patient care, enables telemedicine, and optimizes clinical workflows—but it also introduces cyber risks with life-threatening consequences.
Many devices operate in hospitals for 10–20 years, often without regular updates. Attackers can exploit unpatched firmware, unsecured wireless interfaces, or hospital network gaps.
Add to this the legal weight of HIPAA, GDPR, FDA and MDR regulations—and it becomes clear: cybersecurity is no longer optional, but a core component of responsible medical engineering.
Cyber risk assessments protect more than devices—they protect lives
Medical devices operate in highly regulated environments under extreme safety expectations. Cybersecurity must be designed around risk to patients, data, and therapy continuity. Standards like ISO 14971, IEC 62304, and FDA guidance require manufacturers to assess cyber threats, identify harm scenarios, and implement traceable mitigations throughout the device lifecycle—from development and clinical deployment to long-term maintenance and decommissioning.
Whether hospital-based or wearable, medical devices must secure interfaces to smartphones, networks, and the cloud—especially those handling therapy delivery.
A breached device isn’t just a data risk—it’s a health risk. Risk assessments must combine cybersecurity, privacy, and clinical risk logic.
CYMETRIS supports structured reassessments of risk for aging devices, legacy OSes, and discontinued vendor platforms still in use.
Maximize cybersecurity efficiency across the Healthcare & Medical Devices value chain
Connect with a CYMETRIS Healthcare & Medical Devices expert
See how CYMETRIS can help secure your connected medical technologies—from design to regulatory approval and beyond.