The service supports EIC beneficiaries in understanding the pathway to commercialisation, including associated time and costs. A detailed plan is produced which may de-risk product development and provide clear information to present to investors and other partners. Our approach is as follows: COVARTIM reviews the product maturity, establishes the regulatory pathway (MDR 2017/745 and FDA), identifies QA requirements and creates a product development plan that covers.
These include:
- Regulatory constraints/timelines; Conformity assessment;
- Overall regulatory strategy for the EU and/or FDA, with intended use and indications;
- Product development strategy;
- Key Verification and Validation activities;
- Quality system requirements and set up;
- A Gantt chart including cost and timing estimation of all activities related to product development, production and market introduction.
The service delivery time spans between 4 to 6 weeks.
Daily rate of €950.
Access to Infrastructure & R&D Support
Are you in doubt if this is the right service for you, or do you want to get more information about the service? Get in touch with the EIC Partner providing this service through this query form!
Is this the service you are looking for? If so, you can apply to the service through EIC ACCESS+! Eligible applicants can also get co-funding through the EIC ACCESS+ initiative. Find out more on the project webiste.
Receive up to €60,000 in grants, covering up to 50% of the costs, to access specialised services from the EIC Service Catalogue. Learn more on the EIC ACCESS+ website.