Clariscience regulatory experts will analyse the information and symbology used on the instructions for use, labels and packaging of the different medical devices and IVDs, verifying the correctness and completeness of the information presented with reference to the Regulation and any applicable (harmonised and non-harmonised) standards.
Clariscience regulatory experts will analyse the information and symbology used on the instructions for use, labels and packaging of the different medical devices and IVDs, verifying the correctness and completeness of the information presented with reference to the Regulation and any applicable (harmonised and non-harmonised) standards.
Clariscience may also proceed, upon request, to make the necessary/recommended changes by acting directly on the source graphic files provided by the Company.
The service is useful both to manufacturers of medical devices and IVDs and to distributors and importers who want to register devices in the Medical Device Database and want to ensure that their labelling is compliant.
