Principles for Medical Device Security - Risk Management
Summary: This technical information report provides
medical device manufacturers with guidance
on developing a cybersecurity risk management
process for their products. It blends security
and safety risk management by showing
how to apply the principles presented in
ANSI/AAMI/ISO 14971 Medical Devices—
Application of Risk Management to
Medical Devices, to security threats that
could impact the confidentiality, integrity,
and/or availability of a medical device or
information processed by the device.
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