MDR PACK

This package guides you through the process of setting up a technical file as required by the MDR EU2017/745 Annex II/III. Step by step you will receive all the necessary document templates and instructions that you will need to certify your product. 

• General Safety and Performance Requirements

• Product Classification

• Risk management file

• Usability file

• Applicable Standards and Required Tests

• Clinical Evaluation

• Example agreements for development, suppliers, subcontractors, distributors

• Post-Market Surveillance, Vigilance, Labeling, UDI, and DoC , ...