Skip to product information
1 of 1

ISO 13485 (Clause 4.1) - Software Acceptance Testing

ISO 13485 (Clause 4.1) - Software Acceptance Testing

Regular price £9.99
Regular price Sale price £9.99
Sale Sold out

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

✔ 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?

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.

View full details
  • About Patient Guard

    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.

  • Secure Payment and Document Download

    Our secure system keeps your transaction safe, and the email will be sent promptly to the address you provided. Just click the link to instantly access and download your documents.

  • Contact Us

    For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.