We provide Companies with a team specialised in regulatory affairs and in carrying out systematic literature searches that will endeavour to analyse in depth the characteristics of the medical device or IVD of interest, identifying any critical issues in relation to the applicability of the classification rules set out in the Medical Device Regulation and the IVD Regulation.
We will carry out the appropriate bibliographic research to highlight aspects that are instrumental in determining the correct risk class of the device, such as, for example, the mechanism of action of specific substances – and we will then indicate to the Company the correct classification of the device and the certification path to follow.
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.
