Medea

Medea
Product Description

Medea™ automates the most time-consuming phases of Clinical Evaluation Report production — helping Medical Device compliance teams and CROs meet EU MDR 2017/745 requirements faster, more accurately, and with permanent audit readiness.

The Problem Medea™ SolvesUnder EU MDR 2017/745, every medical device placed on the European market must be supported by a rigorous Clinical Evaluation Report (CER). Each CER requires an average of 120 hours of work — with up to 35% of that time consumed by systematic literature review, evidence appraisal, and risk-benefit analysis.This work is critical. It is also largely manual, highly repetitive, and disproportionately expensive relative to the value it generates. 


Notified Bodies are rejecting an increasing share of submissions for incomplete or poorly structured documentation. 

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Hubmed

  • Country/Region:
    Italy
  • Founded:
    2026
  • On CPHI since:
    2026
  • Employees:
    1 - 24
Company types
Start-up
Primary activities
Technology
View company profile
Categories
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Specifications
  • Selling Points
    Quality Service; Medea™ automates the most time-consuming phases of Clinical Evaluation Report production — helping Medical Device compliance teams and CROs meet EU MDR 2017/745 requirements faster, more accurately, and with permanent audit readiness.
  • Model
    SaaS
  • Supplied from
    Switzerland
  • Measured In
    Euro
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Sales Markets
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Hubmed

  • Country/Region:
    Italy
  • Founded:
    2026
  • On CPHI since:
    2026
  • Employees:
    1 - 24
Company types
Start-up
Primary activities
Technology
View company profile

Hubmed resources (2)

  • HubMed lancia Medea™, la piattaforma AI per la valutazione clinica conforme all’EU MDR

    News 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
    2 Aug 2026
  • 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.

    Video 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.

    Medea™ automates the most time-consuming phases of Clinical Evaluation Report production — helping Medical Device compliance teams and CROs meet EU MDR 2017/745 requirements faster, more accurately, and with permanent audit readiness.

    Who It Is For? 
    Medical Device Compliance Teams In-house regulatory affairs and clinical evaluation teams at Medical Device manufacturers who need to produce, maintain, and update CERs across their product portfolio — without scaling headcount proportionally to the growing MDR documentation burden.

    Contract Research Organizations (CROs) CROs providing clinical evaluation and regulatory affairs services to Medical Device clients, who need to increase throughput, reduce per-CER cost, and deliver consistently high-quality, audit-ready documentation to their clients.
    2026-08-02