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Bug Fix Report

Use this Bug Fixes Documentation List template to systematically record and track the evaluation, corrective actions, testing, and resolution of software bugs in regulated medical device software. Completing this template is essential whenever a software bug is identified and fixed, ensuring compliance with IEC 62304 requirements and supporting robust change management and traceability for audits and regulatory submissions.
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Bug Fixes Documentation List

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1. Scope

This document is a record of the evaluation and implementation of a bug fix according to the company's change management process (SOP Change Management, Consectetur adipiscing elit).

2. Bug ID

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2.1 Date Bug Reported

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2.3 Bug Description

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2.4 Software Product and Version

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2.5 Corrective Action

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2.6 Preventive Action

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2.7 Relevant Software Requirements (if applicable)

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2.8 Relevant Risks

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2.9 Bug Software Test

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2.10 Bug Software Test Results

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2.10 Bug Test Date and Tester

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2.11 Additional Testing Required

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2.12 Updated Software Release

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Mapping of Requirements

Medical Device Certification Made Easy.