Systematic methodologies for identifying biological, software, and cybersecurity hazards in connected healthcare systems.
Risk management requires mapping every potential failure mode to protective software mitigations and physical interlocks. Under ISO 14971:2019, cybersecurity threats that could disrupt life-sustaining telemetry must be analyzed alongside traditional electrical failure modes.
Residual risk must be weighed against demonstrated clinical benefit through structured clinical investigations or extensive post-market clinical follow-up (PMCF) telemetry streams.