Master Software List Template - ISO 13485
Master Software List Template - ISO 13485
Template Overview
Template Overview
Maintain full control and traceability of software used in your Quality Management System (QMS) with our ISO 13485:2016 Clause 4.1 Master Software List Template. Software plays a critical role in medical device manufacturing, quality control, and regulatory compliance, making it essential to document and manage all validated and approved software applications. This structured template provides a centralized system for tracking software details, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, IVDR, and ISO 62304.
Key Features
Key Features
✔ Pre-Formatted Master Software List – Covers key ISO 13485:2016 Clause 4.1 requirements.
✔ Software Inventory & Classification – Record software name, version, intended use, and criticality level.
✔ Validation & Risk Assessment Tracking – Ensure software meets performance and regulatory requirements.
✔ Approval & Change Management Log – Maintain audit-ready documentation of software updates and revalidations.
✔ Compliance with ISO 14971 & Risk-Based Approach – Identify and manage software-related risks.
✔ Editable Digital Format – Fully customizable for different QMS software applications and business needs.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use master software list is ideal for quality managers, IT teams, and regulatory professionals, ensuring a structured, compliant, and well-documented software management process.
Download the ISO 13485:2016 Master Software List Template today and enhance your software compliance and traceability!
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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.
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