ISO 13485 (Clause 4.1) - Master Software List Template for High Risk Devices

Maintain a comprehensive and compliant record of all software used in high-risk medical devices with our ISO 13485:2016 Clause 4.1 Master Software List for High-Risk Devices Template. Proper documentation of software used in high-risk devices is critical for meeting regulatory requirements and ensuring that all systems perform reliably and safely. This ready-to-use template helps organizations create a structured, easily accessible list of all software utilized in high-risk devices, ensuring full traceability and compliance with ISO 13485:2016.

✔ Pre-Formatted Master Software List – Covers all key ISO 13485:2016 Clause 4.1 requirements for high-risk devices.
✔ Software Identification & Classification – Track software names, versions, and classifications for each device.
✔ Regulatory Compliance Tracking – Ensure software meets applicable regulatory standards (e.g., FDA, CE marking).
✔ Validation & Verification Records – Document software validation, testing, and verification activities for each high-risk device.
✔ Version Control & Updates – Maintain an up-to-date history of software versions and changes.
✔ Audit-Ready Documentation – Keep structured records for internal audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various software systems and high-risk device types.

This master software list template is ideal for regulatory affairs teams, quality managers, and compliance officers, ensuring traceability, compliance, and effective software management.

Download the ISO 13485:2016 Master Software List for High-Risk Devices Template today and streamline your software documentation and regulatory compliance!