In light of the changes introduced by the Regulation, Clariscience offers Distributors and Importers of medical devices and IVDs customisable and scalable support to make their organisation compliant with the new regulations.
We provide our customers with a comprehensive service that, starting with an initial meeting to analyse the organisation’s compliance status, will, step by step, lead the Distributor and Importer to meet all applicable requirements in full knowledge.
We will appoint a project leader, experienced in Quality Management Systems, Regulatory Affairs and ISO 9001 and ISO13485 certified lead auditor, who will be responsible for the service provided and the customer relationship.
