Medical Device Cybersecurity
Risk management and vulnerability assessment practices for medical devices, aligned with ISO 14971 and FDA expectations.
ISO 14971 Summary
ISO 14971 defines risk management for medical devices: hazard identification, risk analysis and evaluation, risk control, and residual risk acceptance. Cybersecurity risks are part of this framework. We summarize how to integrate security into the risk management file and production lifecycle. For a full technical treatment, see Medical Device Risk Management (ISO 14971) and our ISO 14971 Checklist.
Vulnerability Assessment Methods Matrix
Passive scanning, firmware analysis, penetration testing, and healthcare-focused CVSS scoring each have a place in medical device security. We provide a matrix of methods, when to use them, and how they map to regulatory expectations. Details in Medical Device Vulnerability Assessment.
Tooling Decision Flowchart
Choosing the right tooling for vulnerability assessment depends on device type, connectivity, and lifecycle stage. We outline a decision flowchart: build vs buy, when to use automated vs manual testing, and how to integrate results into the risk management file.