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Best ISO-14971 Compliance Tools, Checklists & Templates

Table of Contents

ISO 14971 is an international standard that provides a framework for the risk management of medical devices. The standard defines the requirements for risk management and provides a framework for assessing and controlling safety risks associated with medical devices. ISO 14971 is widely adopted, and compliance is mandatory in many regions.

Today, there are three versions of ISO 14971: ISO 14971:2007, EN ISO 14971:2012, and ISO 14971:2019. The European market is covered by the EN standard. Outside of Europe, the most recent standard is ISO 14971:2019. The EN version of the standard adds three new appendices that have their own numbering system, which is not included in the ISO standard.

  • Appendix A (informative) – Overview of risk management
  • Appendix B (informative) – Illustrative examples
  • Appendix C (normative) – Guidance on the application of ISO 14971:2007 to software aspects of medical devices

In this article, we will discuss some great requirements management software organizations can use for ISO-14971 compliance, standard checklist, and essential templates.

Best ISO-14971 Compliance Tools

Visure Requirements ALM Platform

Visure Requirements ALM Platform is a comprehensive tool that supports requirements management and is specifically designed to meet the needs of ISO 14971 risk management processes. It provides a range of features that facilitate compliance with ISO 14971 requirements. Here are some key features of Visure Requirements ALM Platform:

  1. Requirements Management – Visure Requirements ALM Platform allows you to define, manage, and trace requirements throughout the product development lifecycle. It provides capabilities for requirements capture, organization, versioning, and traceability. You can establish links between requirements and other artifacts, such as risks and mitigation measures, ensuring a comprehensive view of the requirements landscape.
  2. Risk Management – Visure Requirements ALM Platform offers robust risk management capabilities aligned with ISO 14971. It enables you to identify hazards, assess risks, and define risk mitigation measures. You can perform risk analysis, evaluate the severity of risks, and track the effectiveness of mitigation actions. The platform helps in documenting risk management activities and maintaining a risk management file as required by ISO 14971.
  3. FMEA Plugin – Visure Requirements ALM Platform provides a FMEA (Failure Mode and Effects Analysis) plugin that enhances the risk management capabilities. FMEA is a systematic technique used to identify and evaluate potential failures and their consequences. The FMEA plugin allows you to perform FMEA analysis, document failure modes, determine their severity, occurrence, and detectability, and establish risk control measures.
  4. Impact Analysis – Visure Requirements ALM Platform facilitates impact analysis, which helps assess the potential effects of changes to requirements, risks, and other related artifacts. You can analyze the impact of changes on the overall system, identify dependencies, and evaluate potential risks introduced by the changes. This helps in maintaining the integrity of the system and ensuring compliance with ISO 14971.
  5. Report Manager – Visure Requirements ALM Platform includes a Report Manager feature that enables the generation of customized reports. You can create reports to document requirements, risks, risk assessments, and mitigation activities. These reports can be tailored to meet the specific reporting needs of ISO 14971, allowing you to demonstrate compliance and provide a clear overview of the risk management process.
  6. Quality Analyzer – Visure Requirements ALM Platform incorporates a Quality Analyzer tool that assists in evaluating the quality of requirements and associated artifacts. It provides metrics and analysis capabilities to assess the completeness, consistency, and correctness of requirements. This helps ensure that requirements meet the necessary standards and contribute to effective risk management.

Visure Requirements ALM Platform offers a comprehensive suite of features to support requirements management and ISO 14971 risk management processes. However, it’s important to evaluate the tool based on your organization’s specific requirements and consider factors such as integration capabilities, scalability, user-friendliness, and cost before making a final decision.

IBM DOORS

IBM Engineering Requirements Management DOORS (formerly IBM Rational DOORS) is a widely used requirements management tool that can be effectively utilized for ISO 14971 compliance. While DOORS does not provide specific features tailored exclusively for ISO 14971, its flexible and customizable nature allows you to adapt it to meet the requirements of the standard. Here’s how IBM DOORS can be utilized for ISO 14971:

  1. Requirements Management: IBM DOORS offers robust capabilities for managing requirements throughout the product development lifecycle. You can define, capture, and organize requirements in a structured manner. DOORS allows you to establish relationships and traceability between requirements and other artifacts, such as hazards, risks, and mitigation measures, ensuring compliance with ISO 14971’s requirement traceability aspect.
  2. Risk Management: Although IBM DOORS does not have dedicated risk management features, you can leverage its flexibility to integrate with external risk management tools or develop custom risk management processes within DOORS. You can create risk-related attributes, link requirements to risks, and track risk assessment and mitigation activities. DOORS also provides the ability to establish risk matrices and calculate risk levels based on severity, probability, and detectability.
  3. Traceability: ISO 14971 emphasizes the importance of traceability between requirements, risks, and other relevant elements. IBM DOORS allows you to establish bidirectional traceability links between different artifacts. You can trace requirements to risks, hazards, design elements, test cases, and other related items. This traceability enables impact analysis and ensures that changes in requirements or risks are appropriately managed and communicated.
  4. Customization and Configuration: IBM DOORS is highly customizable, allowing you to tailor the tool to meet your specific ISO 14971 compliance needs. You can define custom attributes, templates, and workflows aligned with ISO 14971 requirements and terminology. Additionally, DOORS supports the creation of custom reports, which can be used to generate documentation necessary for ISO 14971 compliance, such as risk management files and traceability matrices.
  5. Collaboration and Communication: ISO 14971 emphasizes the importance of collaboration and communication throughout the risk management process. IBM DOORS offers collaboration features, such as real-time multi-user access, discussion threads, and notifications, enabling teams to collaborate effectively. This facilitates communication and information sharing among stakeholders involved in the risk management process.

Intland codebeamer

Intland codeBeamer is a comprehensive application lifecycle management (ALM) and requirements management platform. While it doesn’t have a specific module or integration dedicated to ISO 14971, which is a standard for the application of risk management to medical devices, CodeBeamer can still be used effectively for compliance with ISO 14971 requirements. Here’s how you can use CodeBeamer for ISO 14971 compliance:

  1. Requirements Management: CodeBeamer allows you to define and manage requirements, which is an essential part of risk management. You can create requirements related to risk analysis, mitigation measures, and risk control activities.
  2. Risk Management: CodeBeamer provides features for risk management, such as risk identification, risk assessment, and risk control. You can create risk items, define severity and probability levels, and link them to relevant requirements and design elements.
  3. Traceability: CodeBeamer enables you to establish traceability between different artifacts, such as requirements, risks, and design elements. This traceability helps in demonstrating compliance and facilitates impact analysis.
  4. Document Management: CodeBeamer offers document management capabilities, allowing you to store and version control documents related to risk management. You can create risk management plans, risk assessment reports, and other relevant documents within CodeBeamer.
  5. Workflow and Collaboration: CodeBeamer supports workflow customization and collaboration features, which can be configured to align with your organization’s risk management processes. You can define review and approval workflows for risk-related activities and collaborate with team members involved in risk management.

Siemens Polarion

Siemens Polarion is another popular application lifecycle management (ALM) and requirements management tool that can be used for ISO 14971 compliance. Polarion provides specific features and capabilities that can support organizations in managing risk according to the requirements of ISO 14971, the standard for application of risk management to medical devices.

Here’s how Siemens Polarion can be used for ISO 14971 compliance:

  1. Risk Management: Polarion offers dedicated modules and functionality for risk management. You can create risk items, define severity and probability levels, and assess risks based on these parameters. Polarion allows you to perform risk analysis, evaluate risks, and implement risk control measures.
  2. Traceability: Polarion enables traceability between different artifacts such as requirements, risks, and design elements. You can establish links between risks and relevant requirements or design elements, ensuring traceability throughout the risk management process. This traceability helps in demonstrating compliance and facilitates impact analysis.
  3. Documentation and Reporting: Polarion provides capabilities for creating and managing risk-related documentation. You can generate risk management plans, risk assessment reports, and other necessary documents within the tool. Polarion allows you to customize templates and generate reports to support compliance documentation requirements.
  4. Workflow and Collaboration: Polarion offers workflow customization and collaboration features. You can define workflows for risk management activities, including review and approval processes. Team members can collaborate within Polarion, facilitating communication and coordination throughout the risk management process.
  5. Integration: Polarion supports integration with other tools and systems commonly used in the medical device industry, such as requirements management tools, test management tools, and change management systems. Integration with these systems can further streamline the risk management process and ensure data consistency across different stages of product development.

ReqIF

ReqIF (Requirements Interchange Format) is a standardized format for exchanging requirements information between different requirements management tools. While ReqIF itself is not specific to ISO 14971, it can be used as a means to exchange risk-related information and requirements between tools that support ISO 14971 compliance. 

Here’s how ReqIF can be used for ISO 14971 compliance:

  1. Risk Analysis: ReqIF can be used to exchange risk-related information, such as risk identification, risk assessment, and risk control measures between different requirements management tools. This allows for consistent communication and sharing of risk analysis data across the organization.
  2. Traceability: ReqIF supports the establishment of traceability links between different requirements and artifacts. You can use ReqIF to establish traceability between risk-related requirements and other elements such as design elements, test cases, and verification activities. This traceability helps in demonstrating compliance and facilitates impact analysis.
  3. Documentation and Reporting: ReqIF can be used to exchange risk-related documentation and reports between different tools. You can generate risk management plans, risk assessment reports, and other relevant documents in one tool and export them to ReqIF format for import into other tools. This allows for consistency in risk documentation and reporting across different systems.
  4. Collaboration and Integration: ReqIF enables collaboration and integration between different tools and teams involved in risk management. By exchanging ReqIF files, teams can share risk-related information, collaborate on risk analysis activities, and integrate risk management processes across different tools and systems.

ISO-14971 Compliance Checklist

This checklist outlines key elements to consider when implementing ISO 14971 compliance:

  1. Risk Management Process:
    • Have you established a risk management process that aligns with ISO 14971 requirements?
    • Do you have a defined approach for risk identification, risk analysis, risk evaluation, risk control, and risk communication?
  2. Risk Management Plan:
    • Have you developed a risk management plan that outlines the objectives, scope, and responsibilities for risk management activities?
    • Does the plan address risk management throughout the entire lifecycle of the medical device?
  3. Risk Analysis:
    • Have you identified and documented potential hazards associated with your medical device?
    • Have you assessed the severity and probability of harm associated with each hazard?
    • Have you determined the risk acceptability criteria?
  4. Risk Evaluation:
    • Have you evaluated the overall risk of your medical device based on the results of the risk analysis?
    • Have you considered the acceptability of risk based on the risk acceptability criteria?
  5. Risk Control:
    • Have you implemented risk control measures to mitigate or eliminate identified risks?
    • Have you documented the effectiveness of each risk control measure?
    • Have you considered the principles of the risk control hierarchy (elimination, substitution, engineering controls, warnings, and instructions)?
  6. Residual Risk:
    • Have you assessed and documented the residual risks that remain after implementing risk control measures?
    • Have you justified the acceptability of residual risks based on the overall benefit-risk analysis?
  7. Risk Management File:
    • Have you maintained a risk management file that includes all documentation related to risk management activities?
    • Does the file contain risk management plans, risk analyses, risk evaluations, risk control measures, and residual risk assessments?
  8. Post-market Surveillance:
    • Have you established processes to monitor and evaluate the performance and safety of your medical device in the post-market phase?
    • Do you have mechanisms in place to collect, analyze, and respond to information related to the risks associated with your device?
  9. Risk Communication:
    • Have you established processes to communicate risk-related information to relevant stakeholders, such as users, regulatory authorities, and notified bodies?
    • Do you have appropriate labeling, instructions for use, and warning statements to communicate the risks associated with your medical device?
  10. Documentation and Records:
    • Have you documented all risk management activities and maintained records in accordance with ISO 14971 requirements?
    • Do you have a system in place to ensure the accuracy, integrity, and accessibility of risk management documentation and records?

Remember, this checklist provides a general overview of the key elements of ISO 14971. It’s important to consult the standard itself and work with knowledgeable professionals to ensure thorough compliance with the requirements specific to your medical device and regulatory environment.

Essential ISO-14971 Templates

ISO 14971, the standard for the application of risk management to medical devices, does not provide specific templates for documentation. However, it outlines the essential documentation requirements that should be included in the risk management process. Here are the essential ISO 14971 documentation elements that are typically included:

Risk Management Plan:

This document outlines the approach and objectives for risk management activities throughout the lifecycle of the medical device. It defines the scope, responsibilities, and methods to be used for risk identification, analysis, evaluation, control, and communication.

Risk Management File:

The risk management file contains all the documentation related to risk management activities. It serves as a repository of information and evidence that demonstrates compliance with ISO 14971. The file typically includes all risk analyses, evaluations, control measures, and residual risk assessments.

Hazard Identification:

This document identifies and describes potential hazards associated with the medical device. It includes a comprehensive list of potential hazards that could cause harm to patients, users, or other individuals.

Risk Analysis:

The risk analysis document details the process of analyzing each identified hazard to determine the potential harm it can cause, the likelihood of occurrence, and the severity of harm. It includes methods, criteria, and tools used for risk analysis, such as risk matrices, fault tree analysis, or failure mode and effects analysis (FMEA).

Risk Evaluation:

The risk evaluation document summarizes the results of the risk analysis, assesses the acceptability of risks, and justifies the risk decisions. It outlines the criteria and considerations used to determine whether the risks are acceptable or require further risk control measures.

Risk Control Measures:

This document describes the risk control measures implemented to mitigate or eliminate identified risks. It provides details of the actions taken to reduce the probability or severity of harm associated with each hazard. It may include design changes, safety features, warnings, instructions for use, or protective measures.

Residual Risk Assessment:

The residual risk assessment document identifies and assesses the remaining risks after implementing risk control measures. It documents the justification for accepting residual risks based on a comprehensive benefit-risk analysis and considering factors such as the intended use, patient population, and overall device performance.

Post-Market Surveillance:

This document outlines the processes and procedures for monitoring and evaluating the performance and safety of the medical device in the post-market phase. It includes mechanisms for collecting, analyzing, and responding to information related to risks associated with the device, such as adverse event reporting and post-market surveillance activities.

Risk Communication:

The risk communication document covers the strategies and methods used to communicate risk-related information to various stakeholders. It includes labeling, instructions for use, warning statements, and any other means used to ensure users, healthcare professionals, and regulatory authorities are adequately informed about the risks associated with the device.

It’s important to note that these documentation elements serve as a general guideline, and the specific content and format may vary depending on the organization, product, and regulatory requirements. It’s crucial to tailor the documentation to the specific context of your medical device and seek guidance from regulatory experts or quality management professionals to ensure compliance with ISO 14971.

Conclusion

In conclusion, ISO-14971 is an important quality standard to be aware of in order to ensure medical device safety for both manufacturers and end-users. Through the use of appropriate tools, checklists, and templates, companies can successfully implement the practices outlined for their own risk management processes. Moreover, these same resources can help to identify potential risks early on and easily track those risks throughout the entire product or project lifecycle. For any organization looking for a comprehensive platform that provides support with ISO-14971 compliance tasks, Visure Requirements ALM Platform is worth considering – its comprehensive features will streamline your risk management process and make it easier than ever before. Try out the free 30-day trial at Visure Requirements ALM Platform for an easy start to getting up-to-date with your ISO-14971 requirements.

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