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ISO 14971 gap analysis checklist

ISO 14971 gap analysis checklist

An ISO 14971 gap analysis checklist helps you evaluate your current risk management framework against the standard’s requirements. It identifies areas for improvement, ensuring your processes align with ISO 14971 standards. Use this tool to close compliance gaps and enhance the safety of your medical devices.

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ISO 14971 gap analysis checklist

An ISO 14971 gap analysis checklist helps you evaluate your current risk management framework against the standard’s requirements. It identifies areas for improvement, ensuring your processes align with ISO 14971 standards. Use this tool to close compliance gaps and enhance the safety of your medical devices.

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

Our ISO 14971 gap analysis checklist serves as your roadmap to comprehensive medical device risk management compliance. It breaks down the complex standard into actionable assessment points, allowing you to quickly identify areas needing improvement across your entire risk management process.

With medical device recalls frequently linked to risk management failures, this template helps you avoid costly compliance issues by methodically evaluating your procedures against ISO 14971:2019 requirements. The checklist covers critical areas including risk planning, analysis, evaluation, control, and post-market surveillance, giving you confidence that no aspect of the standard has been overlooked in your implementation.

Related categories

Preview of the template
Entity
General Requirements
Is a risk management process established?
Does the risk management process address all life cycle phases?
Is the risk management process appropriate for the medical device?
Risk Analysis
Are all known and foreseeable hazards identified?
Are risks associated with each hazard estimated?
Are risks categorized based on severity and probability?
Risk Evaluation
Are acceptable risk levels defined?
Are risks compared to the defined acceptable levels?
Are unacceptable risks identified?
Risk Control
Are risk control measures implemented to reduce unacceptable risks?
Are risk control measures verified to be effective?
Are residual risks evaluated and determined to be acceptable?
Overall Residual Risk Acceptability
Is the overall residual risk acceptable?
Are risk/benefit analyses documented?
Are risk management reports prepared?
Risk Management Review
Is the risk management process periodically reviewed?
Are changes to the medical device or its intended use evaluated for new hazards?
Are post-production information sources reviewed for new hazards?
Documentation
Is a risk management file maintained?
Does the risk management file contain all required information?
Is the risk management file reviewed and updated as needed?

Frequently asked questions

What specific sections of ISO 14971 does this gap analysis checklist cover?

This checklist comprehensively covers all major sections of ISO 14971:2019, including risk management planning, risk analysis, risk evaluation, risk control, overall residual risk assessment, and production/post-production activities. It addresses both the process requirements and documentation needs for each section, helping you identify exactly where your implementation may need improvement.

How often should I conduct an ISO 14971 gap analysis for my medical devices?

You should conduct an ISO 14971 gap analysis at least annually, when implementing new risk management processes, before regulatory audits, after significant organizational changes, and whenever the standard has an improvement. Regular assessments ensure continuous compliance and help you proactively address emerging risks before they impact patient safety.

What documentation should I gather before starting the ISO 14971 gap analysis?

Before beginning, gather your risk management plan, risk management file, risk analysis reports, risk evaluation criteria, risk control measures documentation, residual risk assessments, and post-production monitoring records. Having these documents ready will streamline the gap analysis process and ensure you can accurately assess your compliance status.

How can this checklist help prepare for a regulatory audit?

This checklist helps prepare for regulatory audits by identifying compliance gaps before inspectors do. It provides evidence that you’ve systematically evaluated your risk management system against ISO 14971 requirements, demonstrates your commitment to continuous improvement, and gives you time to implement corrective actions for any deficiencies before the audit occurs.

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.