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SOP Change Control (Bundle)

SOP Change Control Bundle_image

CHF150.00

SOP Change Control Template_image

SOP Change Control Template

This is a change control standard operating procedure template. We designed it for medical device companies that want to fast track documenting their change control procedure. It is compatible with ISO 13485, the EU Medical Device Regulations 2017/745 and/or the FDA 21 CFR 820.

Verification Results Template_image

Verification Results Template (Change Control)

This is a verification results template for change control. We designed it for medical device companies that want to document action plans using their own change control procedures. It is compatible with ISO 13485, the EU Medical Device Regulations 2017/745 and/or the FDA 21 CFR 820.

Action Plan Template image

Action Plan Template (Change Control)

This is an action plan template. We designed it for medical device companies that want to document action plans using their own change control procedures. It is compatible with ISO 13485, the EU Medical Device Regulations 2017/745 and/or the FDA 21 CFR 820.

Change Request Template Image

Change Request Template (Change Control)

This is a change request template. We designed it for medical device companies that want to document change requests using their own change control procedures. It is compatible with ISO 13485, the EU Medical Device Regulations 2017/745 and/or the FDA 21 CFR 820.

This is a change control standard operating procedure bundle. It includes a change control SOP template along with all supporting documents such as: change request template, action plan template, and verification results template. We designed it for medical device companies that want to fast track documenting their change control procedure. It is compatible with ISO 13485, the EU Medical Device Regulations 2017/745 and/or the FDA 21 CFR 820.

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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