Medea™
Clinical evidence, made intelligently traceable.
Medea™ is an AI-assisted workspace for Medical Device clinical evaluation. It brings literature research, evidence appraisal and structured CER workflows into one controlled environment. Semantic search and screening accelerate the research-intensive work; traceable links connect source evidence, appraisal parameters and documented conclusions. Qualified professionals retain responsibility for every review, judgement and approval.
EU MDR
Designed for clinical-evaluation workflows under Regulation (EU) 2017/745, including Annex XIV.
Up to 70%
Potential reduction in research-intensive CER work, depending on scope, complexity and team maturity.*
AI-assisted — not AI-driven.
In regulated environments, speed has value only when it is paired with traceability, reproducibility and accountability. Medea™ helps reduce the repetitive burden around clinical evaluation so experts can focus on clinical appraisal, benefit–risk reasoning, quality oversight and patient safety.
A CLEAR ROUTE FROM EVIDENCE TO DECISION
Designed for the work behind a defensible CER.
Medea™ supports Regulatory Affairs, Clinical Evaluation, Quality and Compliance teams at Medical Device manufacturers, as well as CROs. It brings the research-intensive elements of clinical evaluation together in a structured, reviewable workspace.
From digital to AI-assisted quality — each step builds on the last.
1
Search systematically
Define and document literature searches; use semantic search and manage screening at scale.
2
Appraise with context
Organise evidence, source material, filters and appraisal parameters in one controlled workflow.
3
Structure the story
Support State of the Art analysis and documentation aligned with clinical-evaluation workflows.
4
Maintain the audit trail
Keep the route from source evidence to documented conclusion clear and easier to review.
AI accelerates the work. Experts own the decision.
EARLY ADOPTER PROGRAM
Evaluate Medea™ in a real-world workflow.
Open through 31 October 2026Selected Medical Device manufacturers and CROs can access tailored onboarding and contribute practical feedback to the product roadmap.
MEET MEDEA™
CPHI Milan 2026
6–8 October · Fiera MilanoBring greater clarity to your clinical-evidence workflow. Meet the HubMed team or contact us to arrange a personalised demonstration.
* Efficiency estimate concerning the research, screening, appraisal and drafting burden. It is not a substitute for expert review, legal interpretation or regulatory decision-making.
Medea™ supports Medical Device workflows under EU MDR 2017/745. It does not provide legal advice, replace notified-body assessment or remove a manufacturer’s responsibility for regulatory compliance.