QMS (Distributors) Data Analysis Package
The Data Analysis package, as a part of the Quality Management System (QMS), has been developed for distributors of Medical or In Vitro Diagnostic (IVD) devices. The Data Analysis package contains the Data Analysis 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 5.3 Data Analysis Procedure
- T 5.3-1 Example Data Source Template
Please note that once purchased, the product cannot be returned or refunded.
Big Bundle Packages as well available: