QMS (Distributors) Document Requirements Package

The Document Requirements (DRs) package, as a part of Quality Management System (QMS), has been developed for distributors of Medical or In Vitro Diagnostic (IVD) devices. The Document Requirements package contains the Quality Manual and Document Control and Retention Procedure as well as 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 1.0 Quality Manual
  • T 1.0-1 Quality Policy Template
  • SOP 1.1 Document Control and Retention Procedure
  • T 1.1-1 Document Control List 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