QMS (Distributors) Vigilance Requirements Package

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

  • SOP 5.5 Vigilance Procedure
  • T 5.5-1 External Document Register Template
  • T 5.5-2 Recall and Withdrawal Register Template
  • T 5.5-3 Contact Information

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