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System Requirements List

Use this System Requirements List template to clearly define and document all essential system-level requirements for your medical device, ensuring comprehensive traceability and compliance throughout the product development lifecycle. This template should be completed at the early stages of development to guide design, testing, and regulatory submissions, forming the foundation for more detailed subsystem requirements. Properly documenting system requirements is crucial for demonstrating regulatory compliance and aligning stakeholder expectations.
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System Requirements List

ID: Amet1234

1. Purpose

The purpose of this document is to outline the requirements for VelitPro Device. Requirements identified at a system level will be further defined on a subsystem level as part of the product development lifecycle.

2. Scope

This document provides system requirements for VelitPro Device.

3. System Requirements

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