This service can be rendered both at the stage of registration dossier preparation and upon receipt of comments on faults/refusal from RZN.
Documentation assessment includes the check of technical documentation, instructions for use, test results and other documents necessary for medical device registration. The compliance of the device with the requirements of regulatory documents and legislation is assessed during documentation analysis.
Faults can be identified and recommendations for changes can be made during the documentation assessment and analysis. In this case, for the positive registration result, a manufacturer must make the recommended changes to the documentation.
If you contact us, you will have not just an advice, but a full package of documents necessary for effective registration of your medical device.