Change Request Template (Change Control)

Description

This change request template contains all the information you need to get started recording your changes. We designed it for companies that need to comply with:

• ISO 13485,
• EU Medical Device Regulations 2017/745, and
• FDA 21 CFR 820.

This template includes detailed information about how to fill out each section.
It is designed to be used with the company’s own change control procedure, or with a compatible change control procedure from this site.

The change request is the first step to capturing a change. It includes sections that capture the content and reason for a change, an initial impact assessment as well as an impact checklist to help ensure that all aspects are considered including clinical, regulatory, design, manufacturing, etc.

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