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Traceability Matrix

Use this Traceability Matrix template to systematically link regulatory, design, and development requirements to corresponding outputs, such as risk management activities, testing, and verification/validation results for your medical device. This document is essential for demonstrating compliance with ISO 13485 and ISO 14971 and should be completed throughout the product development lifecycle to ensure all requirements are addressed and properly documented for regulatory submissions and audits.
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Traceability Matrix

ID: Volutpat1234

1. Purpose and Scope

The purpose of this document is to provide a traceability matrix for DolorSit Device, developed in compliance with ISO 13485 requirements and ISO 14971 requirements. The traceability matrix provides evidence that regulatory, design, and development requirements are systematically traced to corresponding outputs, including risk management, testing, and verification/validation activities.

2. Traceability Matrix

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3. Risk Traceability Matrix

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