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Technical documentation of medical devices and IVDs

Classification of medical devices and IVDs

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Classification of medical devices and IVDs

Take advantage of a team specializing in regulatory affairs and in conducting bibliographic research to thoroughly analyze the characteristics of your medical device or IVD, identifying any critical aspects regarding the applicability of classification rules outlined in the medical devices regulation and the IVD regulation.

Rely on the most appropriate and accurate bibliographic research that our team will conduct, highlighting all functional aspects such as, for example, the mechanism of action of specific substances, aimed at determining the correct risk class for your medical device under the MDR, or IVD under the IVDR.

The service is useful for companies wishing to accurately assess the materials/substances to be used, the claims to be made on the product, and the complexity of the conformity assessment process for their device, particularly in the early stages of its development.

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Incontra Clariscience al 63° Simposio AFI dal 5 al 7 giugno

Preoccupazione da MDR? Clariscience è la soluzione per i tuoi DM a base di sostanze

Vuoi saperne di più su come possiamo supportarti nell’adeguamento all’MDR per i tuoi dispositivi medici a base di sostanze? Prenota un appuntamento, in occasione del 63° Simposio AFI, potrai incontrare il nostro team.


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