QMS (Distributors) Monitoring of Equipment Requirements Package

The Monitoring of equipment package, as a part of the Quality Management System (QMS), has been developed for distributors of Medical or In Vitro Diagnostic (IVD) devices. The Monitoring of equipment package contains the Calibration 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 – 2)

  • SOP 4.10 Calibration Procedure
  • T 4.10-1 Equipment Calibration Log 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