SOP Change Control Template

Description

This change control standard operating procedure template contains all the information you need to get started to address changes to your medical devices and your quality management system. 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 within your company’s own quality management system, or with a compatible standard operating procedures from this site.

If you want high quality, efficient and lightweight change control process that can be flexibly applied to a company of any size developing medical devices of any complexity, then this is the SOP for you. This process has been streamlined to include only those value-adding steps that meet the regulations and standards so that it doesn’t get in the way of innovation and development of your devices.

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