QMS (Distributors) Change Management Requirements Package

The Change Management package, as a part of the Quality Management System (QMS), has been developed for distributors of Medical or In Vitro Diagnostic (IVD) devices. The Change Management package contains the Change Management Procedure, and 3 related Templates. The package is compliant with ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/46. (number of documents – 4)

• SOP 5.8 Change Management Procedure
• T 5.8-1 Change Request Form Template
• T 5.8-2 Change Control Log Template
• T 5.8-3 Change Control Form Template

Please note that once purchased, the product cannot be returned or refunded.

Big Bundle Packages as well available:

Quality Management System (QMS) (Distributors) Bundle

Quality Management System (QMS) (Distributors) Bundle + Additional Services