ISO 13485 (Clause 4.1) - Software Acceptance Testing
ISO 13485 (Clause 4.1) - Software Acceptance Testing
Template Overview
Template Overview
This ready-to-use acceptance testing template is ideal for quality managers, software validation teams, and regulatory professionals, ensuring a structured, compliant, and effective software approval process.
Download the ISO 13485:2016 Software Acceptance Testing Template today and improve software reliability and compliance!
Key Features
Key Features
✔ Pre-Formatted Software Acceptance Testing Template – Covers key ISO 13485:2016 Clause 4.1 requirements.
✔ Test Plan & Scope Definition – Clearly outline software functions, intended use, and testing objectives.
✔ Test Case Design & Execution Logs – Document test scenarios, expected results, and actual outcomes.
✔ Pass/Fail Criteria & Defect Tracking – Identify and resolve software issues before implementation.
✔ Validation & Risk Assessment Section – Align with ISO 14971 risk management requirements.
✔ Approval & Sign-Off Workflow – Ensure accountability and regulatory compliance.
✔ Editable Digital Format – Fully customizable for different software applications and QMS requirements.
Why choose a QMS Template?
Why choose a QMS Template?
Ensure software used in your Quality Management System (QMS) meets regulatory requirements with our ISO 13485:2016 Clause 4.1 Software Acceptance Testing Template. Software plays a critical role in medical device manufacturing, document control, and quality assurance, making it essential to verify its functionality, reliability, and compliance before use. This structured acceptance testing template provides a systematic framework for evaluating software performance, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, IVDR, and ISO 62304.
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Additional information
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QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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