Service description

A more in-depth description of our services

• Datasets provision and evaluation: Providing datasets and assessing the quality of the data, e.g robustness or representativity, to assist in the improvement of the solutions and its evaluation.
• AI models evaluation: Assessing AI models using additional and/or virtual datasets, simulations and platforms to evaluate performance, cybersecurity, safety and feasibility before physical or clinical trials.
• Regulatory and legal support: Conformity assessment in relation with applicable international, european and/or national requirements such as ethical guidelines (ICH-GCP, etc.), guidances (IEC 62366, IEC 62304, etc. ), norms (ISO 14971, etc.), regulations (MDR, EU AI Act, etc. ), and national laws.
• Controlled environment evaluation: Testing prototypes in controlled physical environments (e.g., anatomical phantoms, cadavers, or motion labs) to simulate real-world conditions without patient interaction.
• Real-world environment workflow evaluation: Testing solutions in live healthcare workflows (e.g., logistics, administrative tasks) to ensure usability, functionality, integration, and efficiency without involving patients. This is non-clinical.
• Real-world environment clinical evaluation: Conducting clinical studies with patients in real-world settings to assess safety, efficacy, and performance of medical devices or AI systems. This is patient-focused.