QMS (Distributors) Resources Requirements Package

The Resources 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 Resource Requirements package contains the Provision of Loan Equipment Procedure, HR and Training Procedure, Device Disposal Procedure and 1 related Template. The package is compliant with ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/46. (number of documents – 4)

  • SOP 3.0 Provision of Loan Equipment Procedure
  • SOP 3.1 HR and Training Procedure
  • T 3.1-1 Training Plan Template
  • SOP 3.2 Device Disposal Procedure

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