THE SERVICE
Concrete support for obtaining CE marking
The support offered specifically covers the phases of research and development and clinical evaluation, including activities such as the preparation of the technical file, dossier preparation, clinical trials/clinical research, examination of technical documentation, audits, and registration in the European database EUDAMED.
OUR TARGET AUDIENCE
Target companies
We cater to established companies, as well as all innovative start-ups and SMEs that need to obtain CE marking for their innovative medical devices to enter the market.
LOOKING FOR HELP?
Seize your opportunity
Are you an SME or a start-up? Are you developing a new device for which you need to obtain CE marking to bring it to market? Do you have a legacy device that you want to certify under MDR/IVDR? Join the project to receive support in the certification process of the technology you are designing.
PROJECTS - Med Fast Track
MED FAST TRACK - FIRST STEP
In the first phase of Med Fast Track, companies will be evaluated based on key areas, such as the innovativeness of the medical device, the identification of needs that will be met by using the device, the market potential, and how structurally ready the company is to enter the market. The projects will be appropriately […]
MED FAST TRACK 2
In the second phase of Med Fast Track, support will be provided for the preliminary feasibility analysis of the clinical investigation. Documentation related to the medical device will be evaluated, and the subsequent definition of the regulatory strategy will be conducted to properly frame both pre-market and post-market clinical investigations.