HubMed lancia Medea™, la piattaforma AI per la valutazione clinica conforme all’EU MDR
HubMed Technologies GmbH, azienda svizzera di software AI dedicata alla trasformazione del ciclo di vita della ricerca e sviluppo (R&D) nelle Life Sciences, ha annunciato il lancio ufficiale di Medea™, una piattaforma basata sull’intelligenza artificiale sviluppata per automatizzare, strutturare e rendere audit-ready i Rapporti di Valutazione Clinica, o Clinical Evaluation Reports (CER), richiesti dal regolamento europeo sui dispositivi medici EU MDR 2017/745.
La soluzione, parte della piattaforma HubMed™, è disponibile da oggi sul mercato in modalità SaaS cloud-based ed è accessibile direttamente via browser, senza necessità di installazione. È pensata in particolare per Contract Research Organizations (CRO) e produttori di dispositivi medici chiamati a operare in un contesto regolatorio sempre più esigente. I primi mercati target indicati dall’azienda sono Italia, Svizzera e Unione Europea. Medea™ consente di ridurre fino al 70% i tempi dedicati alla stesura del CER
What Medea™ DoesMedea™ is a cloud-based AI SaaS platform that automates the research-intensive core of the CER workflow, structured around the requirements of MDR Annex XIV.Automated Literature Search Medea™ conducts systematic, reproducible literature searches across PubMed/MEDLINE and Embase — the two primary databases required by EU MDR — using structured search strings, PICO methodology, and explicit inclusion/exclusion criteria. Every search is documented with full traceability, ready for Notified Body review.AI-Assisted Evidence Appraisal The platform screens, ranks, and appraises retrieved literature against the device's intended purpose and clinical claims — flagging relevant studies, identifying evidence gaps, and structuring findings according to MDR Annex XIV requirements.Risk-Benefit Analysis Support Medea™ structures the risk-benefit analysis framework required under MDR, drawing on appraised clinical data and state-of-the-art (SOTA) evidence to support the clinical evaluation conclusion.Annex XIV-Native Documentation Every output is structured natively around the MDR Annex XIV template — Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) — reducing the time spent on formatting, cross-referencing, and document preparation.Permanent Audit Readiness Full version control, audit trail, and documentation traceability are built into the platform from day one. Every decision, search, and appraisal step is logged — ensuring that the CER can withstand Notified Body scrutiny and post-market audit at any point in time.EUDAMED-Ready Medea™ is designed with the EUDAMED 2026/27 mandatory registration requirements in mind, ensuring that documentation workflows are aligned with the evolving European regulatory infrastructure.Key MetricsMetricValueTime reduction per CERUp to 70% on research-intensive phases.
