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ISO 14971 risk assessment template

ISO 14971 risk assessment template

Use this ISO 14971 risk assessment template to effectively manage medical device risks. It’ll guide you through detailed hazard identification for compliance with industry standards.

Use this template
or download pdf
ISO 14971 risk assessment template

Use this ISO 14971 risk assessment template to effectively manage medical device risks. It’ll guide you through detailed hazard identification for compliance with industry standards.

Use this template
or download pdf

About the ISO 14971 risk assessment template

Risk management and quality assurance are key parts of healthcare product development–which is where standards like ISO 14971 come in. To simplify compliance, use an ISO 14971 risk assessment template that standardizes your evaluations. This template offers a structured approach to analyzing potential issues and applying control measures, improving both safety and efficiency.

By integrating this template into your workflow, you can empower your team to conduct thorough assessments and make data-driven decisions. It’s an invaluable tool for upholding high standards and ensuring reliable results across your projects.

Purpose and benefits of the ISO 14971 risk assessment template

ISO 14971 is the internationally recognized standard that outlines the process for managing risks associated with medical devices. By adhering to this standard, organizations guarantee that their medical devices meet safety requirements and regulatory compliance.

Using an ISO 14971 risk assessment template gives you a clear framework for your processes. By adopting this tool, you can boost productivity and maintain consistency across your assessments. It also makes complex processes more transparent so your team can focus on critical decision-making.

Additionally, the template allows you to identify potential hazards early, minimizing the risk of costly mistakes down the line. It also supports comprehensive documentation, which is vital for audits and regulatory reviews. With easy sharing and collaboration features, you can keep stakeholders aligned on risk management goals, fostering teamwork throughout the process.

How to customize the ISO 14971 risk assessment template

You can tailor the ISO 14971 risk assessment template further to your specific needs to enhance its effectiveness. Here are some ways:

  • Adjust the risk criteria to match your organizational standards. You can input your own risk categories and format them as dropdowns or multiple-choice items so users can simply select them. Make sure to set specific severity and probability scales.
  • Include hazard categories relevant to your products. Add categories that address unique device aspects, such as electrical safety for electronic devices or biocompatibility for implants. If you manufacture wearable health monitors, you can include hazards related to data security.
  • Embed QR codes to relevant guidelines or resources. The form allows you to add QR codes, so you can make ISO standards or internal safety manuals readily accessible through the form.

Download Lumiform’s ISO 14971 risk assessment template today

Improve your risk management process with our specialized template. It guides you through assessing hazards and aligning with regulatory standards so you can conduct thorough, accurate assessments. Implement it now to ensure your medical devices meet top safety standards.

Related categories

  • Risk management and compliance templates
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  • Risk assessment templates
Preview of the template
Page 1
Product Information
Product Name
Product Description
Intended Use
Intended User
Model Number
Version/Revision
Risk Management Process
Risk Management Plan Established
Risk Analysis Conducted
Identified Hazards
Estimated Risk for each Hazard
Risk Evaluation Criteria Defined
Unacceptable Risks Identified
Risk Control Measures Implemented
Residual Risks Evaluated
Overall Residual Risk Acceptable
Risk Management Report Prepared
Risk Analysis
Severity of Harm
Probability of Occurrence
Risk Level
Rationale for Risk Level
Risk Control
Risk Reduction Strategies Considered
Selected Risk Reduction Measures
Residual Risk Evaluation
Verification of Risk Reduction
Effectiveness of Risk Control Measures
Risk Management Report
Report Prepared By
Report Date
Management Approval
Approval Date
Next Review Date

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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.

ISO 13485: A guide to quality management in medical devicesNavigating medical device regulations: Key steps for compliance Your ultimate guide to safety risk assessmentsProduct testing guide: Best practices and strategies
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Template collections

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Top 3 free ISO 14971 risk assessment templates for medical device safety6 free health and safety risk assessment templates6 free stress risk assessment templates45 free risk assessment templates for every industry 
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Use cases

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ISO 14971 softwareRisk management software for anticipating and adressing safety risksRisk assessment softwareQuality Management System (QMS) app
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Quality management process5 lean principles: The cycle of continuous improvementTo whom is continuous improvement importantData gathering and data driven decision making in your business

Frequently asked questions

How can I effectively identify hazards in medical devices?

Start by analyzing the device’s entire lifecycle, from design to disposal. Engage cross-functional teams to brainstorm potential hazards. Use techniques like Failure Mode and Effects Analysis (FMEA) to systematically evaluate each component. With the Lumiform template, you can streamline this process and regularly update your findings to capture new insights and changes in technology.

What is the primary goal of an ISO 14971 risk assessment?

The main objective of an ISO 14971 risk assessment is to systematically pinpoint and control risks associated with medical devices. This process aims to minimize potential harm to patients and users while ensuring compliance with regulatory requirements, ultimately enhancing the safety and effectiveness of the device.

How does ISO 14971 differ from other risk management standards?

ISO 14971 is specifically tailored for medical devices, focusing on patient safety and regulatory compliance. Unlike general standards, it provides detailed guidance on assessing risks throughout the device lifecycle. This leads to a comprehensive approach to identifying and mitigating potential hazards unique to medical products.


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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