The chief obstacles to develop and implement AI algorithms include availability of sufficiently large, curated, and representative training data. Most developers and organizations have limited data access based on small sample sizes, while the preparation of data is a costly and time-consuming process.
Medexprim provides the specific Real-World Imaging Data needed for development, training and validation.
Our solutions will allow you to:
CE (Conformité Européenne) Marking indicates that your medical product complies with the applicable EU regulations and enables its commercialization. Similarly, FDA approval is a prerequisite to gain access to the US market.
When a company seeks CE marking or FDA approval for an AI solution, it needs validation data, and a robust demonstration of the claimed benefit.
Medexprim can help you obtain CE Mark certification or FDA approval, by sourcing the validation data and by setting up the validation process.
Beyond that, with its network of data partners, Medexprim can obtain validation data for other parts of the world, in order to help demonstrate the claimed benefits for local regulatory authorities.
- Access to the specified imaging data needed to reach your goal (adequate volume, quality, specificity)
- Accelerate innovation, development and validation
- Introduce your service / software / product to our network of European hospital partners
- Access to new business opportunities by combining our expertise, tools and networks
Medexprim finds suitable centers amongst its network of data partners to provide the data needed. We demo your service / software / product to the center(s).
We help organize clinical validation for regulatory approvals
We decide on a level of partnership (co-contractor, distributor…), allocate responsibilities for customer and IT support, and help the center(s) with operational project matters.
We provide a technical and contractual framework to ensure data security and GDPR compliance.
"At Medexprim, they are very responsive and flexible, which is why I like working with them. From the moment we work together on a project, they adapt as needed, even if it requires doing things they don’t usually do. They are very rigorous, they provide clean work, they know the regulations, they know how to be pragmatic in moving projects forward."