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Technical documentation of medical devices and IVDs

Labelling compliance analysis

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Labelling compliance analysis

Whether you’re a manufacturer, distributor, or importer of medical devices and IVDs, our goal is to help you register your devices in the Medical Device Database while ensuring your labeling is spot-on compliant.

Our regulatory experts dive into every detail of your device’s instructions for use, labels, and packaging. We leave no stone unturned, checking for accuracy and completeness against the Regulation and relevant standards, whether harmonized or not.

If your packaging and/or IFU need any change, we’ll handle it seamlessly. Just provide us with your graphic files, and we’ll take care of the rest.

This service is designed for both manufacturers of medical devices and IVDs and distributors and importers who want to register devices in the Medical Device Database and want to ensure that their labelling is fully compliant.

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