Risk Analysis - Software - ISO 13485

Effectively identify, analyze, and control risks associated with software used in medical device Quality Management Systems (QMS) with our ISO 13485:2016 Clause 4.1 Software Risk Identification, Analysis & Control Template. Software used in QMS processes must be validated and monitored to ensure compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, IVDR, and ISO 14971. This structured template provides a comprehensive framework for assessing software risks, tracking mitigation strategies, and maintaining regulatory compliance.

✔ Pre-Formatted Software Risk Identification & Analysis Template – Covers key ISO 13485:2016 Clause 4.1 requirements.

✔ Software Risk Assessment Checklist – Identify potential software failures, vulnerabilities, and regulatory concerns.

✔ Risk Analysis & Scoring Matrix – Evaluate risk severity, occurrence likelihood, and potential impact.

✔ Risk Control & Mitigation Strategies – Define preventive actions, validation procedures, and software updates.

✔ Compliance with ISO 14971 & Risk Management Integration – Ensure proper risk documentation.

✔ Traceability & Regulatory Documentation – Maintain audit-ready risk records.

✔ Editable Digital Format – Fully customizable for different software applications and business needs.

This ready-to-use template is ideal for quality managers, regulatory professionals, and IT teams, ensuring a structured, compliant, and effective approach to software risk management.

Download the ISO 13485:2016 Software Risk Identification, Analysis & Control Template today and enhance regulatory compliance and software reliability!