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ISO 14971:2019 checklist

ISO 14971:2019 checklist

The ISO 14971:2019 checklist helps medical device manufacturers identify, assess, and manage risks throughout the product lifecycle. It provides a structured approach to meeting the standard’s requirements, ensuring product safety and regulatory compliance. Use this tool to strengthen your risk management processes and protect patient safety.

Use this template
or download pdf
ISO 14971:2019 checklist

The ISO 14971:2019 checklist helps medical device manufacturers identify, assess, and manage risks throughout the product lifecycle. It provides a structured approach to meeting the standard’s requirements, ensuring product safety and regulatory compliance. Use this tool to strengthen your risk management processes and protect patient safety.

Use this template
or download pdf

About the ISO 14971:2019 checklist

Managing risks in medical device development can be overwhelming without a clear framework. An ISO 14971:2019 checklist helps you standardize your risk management process and ensure compliance with international standards. 

You can use this checklist to identify hazards, evaluate risks, and document mitigation measures, ensuring the safety and reliability of your devices while simplifying audits and regulatory reviews. 

How to use an ISO 14971:2019 checklist

Using an ISO 14971:2019 checklist effectively ensures your medical devices meet safety and compliance standards. Follow these steps to integrate the checklist seamlessly into your workflow: 

  1. Customize the checklist: Begin by tailoring the template to your specific device and processes. Add fields to address unique hazards, device functions, or regulatory requirements to ensure it fits your risk management framework. 
  2. Identify hazards and risks: Use the checklist to systematically document potential hazards associated with your device. Include factors like user errors, environmental conditions, or design flaws. A clear structure ensures no risks are overlooked during the assessment. 
  3. Evaluate and prioritize risks: Assess the likelihood and severity of each identified risk. Use the checklist to record this data, helping you prioritize which risks need immediate attention and mitigation. 
  4. Develop and implement mitigation plans: Document corrective actions directly in the checklist. Assign responsibilities to team members and track progress to ensure all risks are addressed effectively and on time. 
  5. Review and update regularly: Risk management is an ongoing process. Use the checklist to conduct regular reviews, update risk assessments, and ensure compliance with ISO 14971:2019 standards as your device evolves. 

This structured approach helps you streamline your risk management process and ensures your team works collaboratively to meet safety and regulatory requirements. 

When to use an ISO 14971:2019 checklist

You should use an ISO 14971:2019 checklist whenever you need to ensure compliance with risk management standards for medical devices. It’s particularly beneficial during product development, helping you identify and mitigate potential hazards early in the design phase. 

This checklist is also essential during regulatory audits or when preparing documentation for approval by authorities. It ensures your risk management processes are thorough and well-documented. 

If your team is conducting periodic risk reviews or updating an existing device, the checklist helps you reassess risks as new data becomes available, ensuring continued compliance and safety. 

A template such as this serves you by streamlining your risk management efforts, reducing errors, and improving collaboration across your team. Use it to stay proactive and maintain high safety standards throughout your device’s lifecycle. 

Start managing medical device risks today 

Take control of your medical device risk management with an ISO 14971:2019 checklist. With its customizable design and user-friendly features, you can tailor the checklist to your processes and ensure your devices meet the highest safety standards. 

Related categories

  • Health and safety management templates
  • Health care templates
  • ISO templates
Preview of the template
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Hazard Identification
Have all reasonably foreseeable hazards been identified?
Have all potential harm situations been identified?
Has information from similar products been considered?
Have all process-related hazards been identified?
Risk Estimation
Have the severity of harm, probability of occurrence, and detectability of each hazard been estimated?
Have risk estimation methods been documented?
Have the risk estimation methods been validated?
Risk Evaluation
Have the acceptable levels of risk been defined?
Have the risks been compared to the defined acceptable levels?
Have the risk evaluation results been documented?
Risk Control
Have the risk control measures been implemented?
Have the risk control measures been verified?
Have the risk control measures been validated?
Have the risk control measures been monitored for effectiveness?
Customization
Has the checklist been customized for the specific device or product line?

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Related resources

Access a complete set of resources aimed at maximizing safety, quality, and operational excellence, including detailed guides, related templates, and real-world use cases.

Topic guides

Read in-depth guides covering key topics related to this article.

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See comprehensive collections of best practice templates related to this topic.

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Frequently asked questions

What is an ISO 14971:2019 checklist used for?

An ISO 14971:2019 checklist is used to manage risks during the development and production of medical devices. It helps identify potential hazards, assess risks, and document mitigation measures, ensuring compliance with international safety standards and improving the reliability of medical devices.

Why is risk management important for medical devices?

Risk management ensures medical devices are safe and effective for users. It helps identify and address potential hazards early in the development process, reducing the likelihood of failures, recalls, or regulatory penalties. Proper risk management also builds trust with regulators and end-users, ensuring devices meet high safety standards.

Who benefits from using an ISO 14971:2019 checklist?

Medical device manufacturers, quality assurance teams, and regulatory compliance officers benefit most from using this checklist. It’s especially valuable during audits, product development, and periodic risk reviews, helping teams ensure devices meet safety standards and regulatory requirements efficiently.

How can regular risk reviews improve medical device safety?

Regular risk reviews help identify new hazards, reassess existing risks, and ensure mitigation measures remain effective. They ensure compliance with evolving regulations and maintain the safety and performance of medical devices throughout their lifecycle, reducing the risk of failures or user harm.


This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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