MDR Compliance
VLF Consulting supports companies in filling technical files in compliance with the standards and regulations in force for obtaining the CE product marking (MDR 2017/745, IVDR 2017/746).

International regulatory consultancy
VLF Consulting develops consultancy projects in the regulatory field, supporting companies for feasibility studies and preparation of the documentary package to be submitted to the Competent Authorities of all countries in the world.

US market: FDA Registrations, Establishment Registration, and Listing
VLF Consulting deals with the US market by supporting companies in registration practices with the FDA, (e.g. 510k), also following the annual Establishment Registration and Listing activities with the FDA, with particular attention to the reduced rates potentially applicable to its customers.

VLF Consulting assists medical companies in terms of surveillance: incident management and notification to the competent authorities.

Market Access
VLF Consulting carries out registrations of in vitro medical and medical-diagnostic devices in the databases of the Italian and European Ministries of Health. It also deals with Market Access at a regional level, supporting customers in the activities of inclusion in regional handbooks and pharmaceutical databases and in obtaining the necessary information for the reimbursement of devices.

Health advertising and free sale certificates
VLF Consulting offers support in requesting authorization and reviewing advertising material; also assists in obtaining free sales certificates.