Carexdata

Carexdata is a Boston-based AI consultancy founded in 2025 that helps healthcare organizations and medical device manufacturers verify AI-powered software meets regulatory standards before patient use. The company offers strategy services focused on compliance verification for medical AI, auditing training data, models, source code, and submission documents against FDA, EU MDR, and EU AI Act requirements. It operates as a one-person firm providing automated assessments and audit-ready evidence packages that run inside the client's network.