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Design Review Checklist

Use this Design Review Checklist template to ensure all design inputs for your medical device are thoroughly verified against user needs and regulatory requirements. Complete this checklist at each design review milestone to document compliance, identify gaps, and support your design validation process for both software and physical products. This tool is essential for maintaining quality assurance and meeting regulatory expectations during product development.
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Design Review Checklist

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1. Purpose

This checklist is used to verify that the design of the product is confirmed and the design inputs were properly generated based on the user needs.

2. Scope

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2. Design Review Checklist

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Software Products

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Physical Products

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Medical Device Certification Made Easy.