Description
This change control standard operating procedure bundle contains all the information and documentation templates 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:
This bundle includes:
- a lightweight, efficient change control procedure that meets regulations and standards,
- a change request template,
- an action plan template, and
- a verification results template.
If you want high quality, efficient and lightweight complete 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.
Need help building your quality management system? Check out our consulting offering to see how we can help you!
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