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: