Risk Management Report

1. What this module does

You set the acceptability threshold and list each hazardous situation with its severity, probability, risk control, control type, verification and residual probability.

The tool scores the risk before and after control, flags situations not acceptable without a control, unverified controls, information for safety used alone for serious harms, residual risks needing a benefit-risk analysis, and a missing overall evaluation, review or post-production plan.

What you get

• A Word or PDF file: risk management report.

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

• The risk management plan with the acceptability policy.
• The hazard analysis.
• Verification evidence for each risk control.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/risk-management-report.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

1. Set the policy

   Give the acceptability threshold (severity × probability) and tick the overall residual risk evaluation and the review.

   

2. Enter the hazard analysis

   One row per hazardous situation. Control type is design, protective or information.

3. Read the result

   The headline gives the outcome, for example "1 critical issue in the risk management report".

   

4. Resolve alerts and download

   Unverified controls, unacceptable risks without a control or without a benefit-risk analysis, and no overall evaluation are critical. Then preview and download.

   

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Device and policy

2 · Hazard analysis

One row per hazardous situation. Control type: design, protective or information. Verified: yes when implementation and effectiveness are verified.

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

• Risk before and after control.
• Control priority and verification.
• Benefit-risk, overall residual risk and post-production.

How to resolve alerts

• Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
• Major alerts block the download until you fix them or type a justification and press Accept justification.
• Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
• Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: Conclusion. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

1. Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
2. The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
3. Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
4. Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
5. Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

ISO 14971:2019 is recognised by FDA and harmonised under the EU MDR; the EU also needs risks reduced as far as possible (Annex I).

8. Working with other modules

• Risk controls are traced in the Design History File.

9. Common pitfalls

• Relying on a warning in the IFU for a serious harm.
• Releasing with unverified risk controls.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

1. Verify the network control

   Mark the HZ-07 control as verified.

   Expected resultAll residual risks are acceptable.