Medical Device Security Assessment
Evaluate cyber risk in connected medical devices without disrupting clinical operations.
Connected medical devices introduce unique security challenges — constrained hardware, long lifecycles, patient safety implications, and regulatory complexity under MDR, FDA cybersecurity guidance, and IEC 62443. Mitigence assesses device risk with clinical context, not just a generic vulnerability scanner.
Engagement Phases
Device Inventory & Classification
2–3 daysCatalogue all connected medical devices, classify by patient contact, data sensitivity, and network connectivity.
Threat Modelling
3–4 daysModel realistic attack scenarios per device class — considering both cyber and patient safety impacts.
Technical Assessment
4–6 daysNon-disruptive technical testing: network traffic analysis, firmware review where accessible, and interface security evaluation.
Clinical Impact Analysis
2–3 daysMap technical findings to clinical operational risk and patient safety implications with clinical input.
Reporting & Remediation Planning
2–3 daysRisk-rated report with short-term compensating controls and long-term remediation guidance.
What You Receive
- Medical device inventory and risk classification
- Device-level threat model
- Technical findings report with clinical risk context
- Compensating control recommendations
- Remediation roadmap aligned to device lifecycle
- Regulatory alignment notes (MDR / FDA / IEC 62443)
Ready to scope this engagement?
Tell us about your environment and objectives — we'll map the approach to your context.