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Change Request

Use this Change Request template to formally document and initiate modifications to already released medical devices, ensuring all proposed changes are assessed and approved by the product, quality, and business teams. This form is essential for maintaining compliance with change management procedures and should be filled out whenever you need to propose, evaluate, or track product or process changes. Proper completion supports regulatory requirements, traceability, and risk management throughout the product lifecycle.
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Change Request

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1. Scope

This document is a request form to initiate a change for an already released product according to SOP Change Management Consectetur adipiscing elit. The change request is reviewed by the quality team, product team, and the business team.

2. Change Request

2.1 Source of Change Request

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2.2 Description of Change

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2.3 Affected Products and Versions

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2.4 Affected Software Items

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2.5 Anticipated Impacts of Change

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3. Responsibilities

Approval of this document indicates an understanding and agreement with the changes requested as being feasible and necessary.

4. Responsibilities

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