QMS (Distributors) Translation Requirements Package
The Translation package, as a part of the Quality Management System (QMS), has been developed for distributors of Medical or In Vitro Diagnostic (IVD) devices. The Translation package contains the Translation Management 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 6.0 Translation Management Procedure
- T 6.0-1 Translation Verification Form Template
Please note that once purchased, the product cannot be returned or refunded.
Big Bundle Packages as well available: