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ISO 14971:2019 checklist

ISO 14971:2019 checklist

The checklist helps medical device manufacturers identify, assess, and manage risks throughout the product lifecycle.

Use this template with Lumiform

The Lumiform application helps frontline teams uphold internal standards effortlessly.
  • Customize this template or build your own
  • Fill out templates via mobile app
  • Assign and track corrective actions
  • Get reports and analyse your data
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ISO 14971:2019 checklist

The checklist helps medical device manufacturers identify, assess, and manage risks throughout the product lifecycle.

Use this template with Lumiform

The Lumiform application helps frontline teams uphold internal standards effortlessly.
  • Customize this template or build your own
  • Fill out templates via mobile app
  • Assign and track corrective actions
  • Get reports and analyse your data
Prices start from ░░░ per month
Book a demo
Learn more
or Download template as PDF

This ISO 14971:2019 checklist supports you in checking if your medical device risk management process meets regulatory requirements. It methodically guides you through verifying hazard identification, risk estimation, evaluation, and control implementation, which are critical areas where auditors frequently find non-conformities. When preparing for regulatory submissions, you can quickly identify gaps in your risk documentation that might otherwise delay approval.

Healthcare ranked among the top 10 industries that received the most cyberthreats, according to IBM. The rising complexity of compliance makes systematic verification tools essential for maintaining both patient safety and data security in medical device development.

Related categories

Preview of the template
Entity
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?

Frequently asked questions

How can I use this ISO 14971:2019 checklist most effectively during an audit?

Customize the checklist, then review your risk management file at least two weeks before scheduled audits. Focus first on any “NO” responses, which represent immediate gaps requiring correction. Prepare supporting evidence for each “YES” answer, ensuring documentation is readily accessible and organized according to the checklist sections for efficient auditor review.

What’s the best way to customize this ISO 14971:2019 checklist for my specific medical device?

Begin by adding device-specific hazards relevant to your product’s technology, use environment, and user profile. Adjust the risk estimation section to reflect your company’s specific scoring methodology. Include references to your internal procedures and acceptance criteria to create a seamless connection with your quality management system.

What documentation should I prepare to demonstrate that risk control measures have been verified?

Prepare test reports showing each control measure functions as intended under normal and fault conditions. Include design verification records demonstrating specifications are met, and validation data showing risk controls are effective in the actual use environment. Ensure traceability between each identified risk and its corresponding control verification.

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.