Action Plan Template (Change Control)

Description

This action plan template contains all the information you need to get started recording the action plan to address 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 action plan is a crucial step to in implementing a change. It includes sections that capture the activities required, an evaluation of resources as well as an impact checklist to help ensure that all aspects are considered including clinical, regulatory, design, manufacturing, etc.

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