Access to Infrastructure & R&D Support service
Development Plan
Provided by COVARTIM · Belgium
Service description
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.