QMS (Distributors) UDI & Labelling Requirements Package
The UDI & labelling package, as a part of the Quality Management System (QMS), has been developed for distributors of Medical or In Vitro Diagnostic (IVD) devices. The UDI & labelling package contains the UDI & labelling Procedure. The package is compliant with ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/46. (number of documents – 1)
- SOP 4.7 UDI & Labelling Procedure
Please note that once purchased, the product cannot be returned or refunded.
Big Bundle Packages as well available: