Risk control option analysis

Clause 5.4 of ISO 14971:2019 governs risk control option analysis — how a medical-device manufacturer chooses measures to reduce a risk. It sets a mandatory priority order: first inherent safety by design, then protective measures in the device or manufacturing process, and only then information for safety (warnings, instructions, training). Each selected control must reduce risk as far as reasonably practicable without adversely shifting the benefit-risk balance, and every control links back to the hazard it addresses. It is the backbone of a defensible risk-management file.