QMS (Distributors) Complaint Handling Requirements Package

The Complaint Handling package, as a part of the Quality Management System (QMS), has been developed for distributors of Medical or In Vitro Diagnostic (IVD) devices. The Complaint Handling package contains the Complaint Handling Procedure, and 2 related Templates. The package is compliant with ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/46. (number of documents – 3)

  • SOP 5.7 Complaint Handling Procedure
  • T 5.7-1 Incident Report Template
  • T 5.7-2 Complaint Register 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