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Site conducted
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Conducted on
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ISO 14971 Checklist
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Before accomplishing this checklist, make sure you:
- Know the necessary risk management plans in place for a specific device, part, or product
- Remember to cross-reference all findings here with your risk management plans after
- Contact the necessary people to address any issues with risk management and compliance -
Repeat the following section per medical device to inspect.
Risk Management for Medical Device
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What is the product or part being managed or questioned?
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What hazard(s) or risk(s) can this product or part bring to the company or its intended user?
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What is its risk level?
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How can the identified hazard(s) or risk(s) harm the company or its users?
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What measures should be taken to reduce or eliminate these risks?
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What other kinds of risks are left behind or can be left behind after implementing mitigation plans?
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What conclusion can be drawn from after taking the necessary steps to reduce or eliminate risks and hazards?
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Recommendations
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