Risk Analysis - Software - ISO 13485

Risk Analysis - Software - ISO 13485

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ISO 13485:2016 QMS Template - Risk Identification Analysis & Control - Software (QMS.4.1.6.3 - QT)

Enhance your Quality Management System with our ISO 13485:2016 compliant Risk Identification Analysis & Control - Software template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?


Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.

Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.

Compliance Assurance: Utilizing our template helps you maintain effective risk identification, analysis, and control procedures, demonstrating robust quality management as required by ISO 13485:2016.

When Do You Need to Perform Software Risk Assessment?


If the use of a piece of software is deemed to have associated risks, the known and foreseeable hazards should be identified. The potential harm and probability of occurrence related to these hazards should be analyzed. Risk mitigation actions should be considered and implemented to ensure safety and compliance.

Which Clause Within the ISO 13485 Standard Will This Template Help Our Company Comply With?


The software risk analysis and control template will aid your compliance with Clause 4.1.6, which states: “The specific approach and activities associated with software validation and re-validation shall be proportionate to the risk associated with the use of the software.”

Do You Require Any Supporting Documents?

Additional templates that may interest you include:

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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