Chip lifecycle / Work products / Security risk management report

Security risk management report

The report of cybersecurity risk management for the device software and connectivity: threats, vulnerabilities, controls, residual security risk and links to safety risk.

Report Work product in the Medical electronics and medical device chips lifecycle

Why it exists and what it decides

Regulators expect connected devices to have documented security risk management alongside safety risk management. Unassessed vulnerabilities that could harm patients or expose health data invite a challenge to the submission and leave post-market vulnerability handling with no baseline.

Decisions it informs

Whether residual security risk is acceptable for the software release
Which security controls must be in place before release
Which security risks could also affect patient safety and must enter the hazard analysis

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