ISO 14971 Checklist Template
This checklist for medical device manufacturers is based on the scope, description, and guidelines of the ISO 14971 standard. It can be used to perform risk management checks on medical devices. Repeat sections as needed for each medical device or part and use the guide questions to perform a thorough inspection of your products.
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How to Use This Checklist
- Describe the medical device or part being reviewed and the hazards or risks it may present to the business or its potential user.
- Assign a risk level for each hazard: high, medium, or low.
- Explain how the identified hazards or risks could harm the business or its users.
- Define the measures to reduce or eliminate those risks.
- Record the risks that remain or may remain after the reduction plans are in place.
- State the conclusion drawn once the measures to reduce or eliminate the risks and hazards have been taken.
- Add recommendations, then sign and close the record.
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What risk management for medical devices covers
Risk management for medical devices is the work of finding out what could go wrong with a device, deciding how serious it would be, and putting measures in place to reduce or remove the danger. The ISO 14971 standard sets out the scope, description, and guidelines this checklist follows, and this template turns that framework into a set of questions you answer for each device or part you review. Done properly, this work touches both the business and the people who use the device. A hazard that is not identified is a hazard that cannot be controlled, so the process is as much about documentation and judgement as it is about testing.
Why the process matters
For a medical device manufacturer, risk management is not a one-off exercise. It is how you demonstrate that you have thought about what your device could do to a patient or user and taken steps to keep it safe. The checklist has you name each hazard, rate its risk level, and describe how it could harm the business or its users. That forces the reasoning out of people's heads and onto the record, where it can be reviewed, repeated, and signed off. It also matters commercially, because the risks you accept shape the controls you commit to. The checklist keeps the two connected: every identified risk leads to a measure, and every measure leaves a trace of what is still left over.
What a good assessment covers
Use the checklist's guide questions as a structure. A complete pass through the template covers: - **The product or part under review** — name exactly what is being assessed so the record is traceable. - **The hazards or risks it may present** — identify what could cause harm to the business or to a potential user. - **The risk level** — rate it as high, medium, or low so the relative severity is visible. - **The harm pathway** — describe how the identified hazards or risks could actually hurt the business or its users. - **The reduction measures** — set out the steps to reduce or eliminate the risks. - **Residual risks** — record what remains, or could remain, after those measures are applied. - **The conclusion** — summarise what the assessment shows once the measures have been taken. The checklist also captures who conducted the review, who prepared it, where it took place, and the person's signature, so the record can be attributed and verified.
How to carry it out
1. **Identify the device.** Answer what product or part is being taken on or called into question. Repeat the sections as needed for each medical device or part you review. 2. **Surface the hazards.** Ask what dangers or risks the device or part could bring to the business or its potential user. 3. **Rate the risk.** Choose a level of high, medium, or low for each hazard. 4. **Trace the harm.** Explain how the hazard or risk would actually harm the business or its users. 5. **Plan the controls.** List the measures to reduce or eliminate the risk. 6. **Check what remains.** Record the other risks that persist or could persist after the reduction plan is in place. 7. **Draw the conclusion.** Write what you can say after the measures to reduce or eliminate the risks and hazards have been taken. 8. **Close the record.** Add recommendations, sign, and record the dates and times of the inspection. Work through the guide questions at a pace that lets you think about the answer rather than tick a box. If a hazard has no clear control, that is itself a finding worth recording.
Common pitfalls
The most common weakness in a risk assessment is stopping at the hazard. If you list a risk but do not say how it could harm someone, you cannot judge the control. The second is skipping the residual risks. Reduction measures rarely remove a risk entirely, and the checklist asks specifically about what is left over. The third is leaving the levels unset. High, medium, and low are not decoration; they tell the next reader which risks deserve attention first. Finally, keep the record attributable. Without the preparing person, the location, the dates, and the signature, a thorough assessment is hard to trust later.
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