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.
