ISO 14971 Risk Management for Medical Device Software with CppDepend

ISO 14971 is the international standard for risk management of medical devices. It requires manufacturers to identify hazards, estimate and evaluate risks, implement risk-control measures and verify their effectiveness across the device lifecycle. For software, many risk controls are implemented in code — bounds checks, fail-safe states, watchdogs, defensive design — and auditors expect objective proof that these controls exist and keep working.

Software Risk Controls Under ISO 14971

• Implementation of risk controls: every software-Implemented risk control must be traceable to the risk analysis.
• Verification of effectiveness: evidence that controls behave as intended and were not weakened by later changes.
• Residual-risk monitoring: complexity and defect trends feed the post-production risk picture.
• Lifecycle integration: risk management runs alongside the IEC 62304 software lifecycle.

How CppDepend Supports ISO 14971 Teams

• Risk-control-as-code: express critical controls as custom CQLinq rules — e.g. “every sensor read must be range-checked” — and verify them on every build.
• Regression evidence: baseline comparisons prove no risk-control code was removed or bypassed between releases.
• Architecture isolation: keep risk-critical components separated and auditable with enforced dependency rules.
• Quality trend reporting: violation and complexity trends support residual-risk evaluation and management reviews.
• Audit-ready exports: reports slot directly into the risk-management file next to IEC 62304 verification records.

Related Industries & Case Studies

• Case study: IEC 62304 compliance in embedded medical devices

Related Coding Standards

IEC 62304 · MISRA C · IEC 61508 · CERT C