QMS (Distributors) Computer & Software Requirements Package
The Computer & software package, as a part of the Quality Management System (QMS), has been developed for distributors of Medical or In Vitro Diagnostic (IVD) devices. The Computer and software package contains the Computer validation, backup and protection Procedure. The package is compliant with ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/46. (number of documents – 1)
- SOP 4.9 Computer Validation, Backup and Protection 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
150,00 €