QMS (Distributors) Management Requirements Package

The Management Requirements package, as a part of the Quality Management System (QMS), has been developed for distributors of Medical or In Vitro Diagnostic (IVD) devices. The Management Requirements package contains the Management Responsibilities Procedure, Management Review Procedure and 2 related Templates. The package is compliant with ISO 13485:2016, EU MDR 2017/745, EU IVDR 2017/46, and the General Data Protection Regulation (GDPR). (number of documents – 4)

• SOP 2.0 Management Responsibilities Procedure
• SOP 2.1 Management Review Procedure
• T 2.1-1 Management Review Report Template
• T 2.1-2 Management Review 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