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ISO 14971 risk assessment template

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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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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.

Please note that this checklist template is a hypothetical appuses-hero example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.