Demo — this interview is built and live in Indelio’s Risk Management module. Nothing you type here is saved or sent anywhere.

Try the risk-item interview

Sample assessment · RA-001 — Glucose meter — design risk analysis

Adding risk item #1 to RA-001

In Indelio, the form on the assessment page saves exactly the same fields.

Add a risk item

Let’s add one risk, one question at a time.

About a dozen short questions, in the order ISO 14971 works through a risk. In Indelio the answers are saved to the same risk item the form edits, so its review and its signatures work exactly as they do for any other item.

Identify — what could cause harm, how it would reach someone, and the harm itself
Estimate — how bad, and how likely, before any control
Control — the highest §7.1 option that is practicable, and the control itself
Residual — the same two scores after the control, and whether what is left is acceptable
Verify — how you will show the control works, then one screen to check it all

People who already know ISO 14971 keep the form. This is another way in, not a replacement.

The questions, labels, 1–5 scales, score bands and the three §7.1 control options on this page are the ones in Indelio’s risk-item interview, and an automated test compares this page with the product’s interview on every change. In Indelio the answers are saved to the risk assessment; this page keeps them only while it is open. The example device, the assessment and the answers are fictional.

The interview is one way into Indelio’s Risk Management module.

Assessments, risk items, residual scoring and the signed review and approval are in the module.

See Risk Management Start free trial

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