Skip to Content

HubMed™ Launches Medea™: The First AI-Powered Clinical Evaluation Platform Purpose-Built for EU MDR Compliance

LUGANO, SWITZERLAND – June 21, 2026 – HubMed Technologies GmbH, the Swiss-made AI software company dedicated to transforming the life science R&D lifecycle, today officially launched Medea™ — the first AI-powered solution purpose-built to automate, structure, and audit-proof Clinical Evaluation Reports (CERs) under EU MDR 2017/745.

Available immediately as a cloud-based SaaS solution, Medea™ is designed for Contract Research Organizations (CROs) and Medical Device manufacturers operating under the stringent documentation requirements of the European Medical Device Regulation. The solution, part of the HubMed™ platform, is accessible via browser with no installation required and includes a free trial. Initial target markets include Italy, Switzerland, and the broader European Union.

 

A Market Under Pressure — and a Platform Built to Respond

The EU MDR has fundamentally raised the bar for clinical documentation. Since its full applicability in May 2021, Notified Bodies have reported a surge in MDR applications — from 1,661 in 2020 to over 14,500 in 2023 — while certification rates have struggled to keep pace, with a significant proportion of applications delayed or requiring extensive remediation. Industry surveys consistently identify deficiencies in clinical evaluation documentation — in particular inadequate literature reviews, incomplete evidence appraisals, and unstructured risk-benefit analyses — as the primary causes of audit findings and conformity assessment failures.

Against this backdrop, the Clinical Evaluation Report has become the most scrutinized document in the entire technical file, and the most resource-intensive to produce. Each CER requires an average of 120 hours of compliance work, of which approximately 35% is dedicated to the research-intensive phase: systematic literature review, evidence appraisal, risk-benefit analysis, and technical annexes. This is precisely where Medea™ has the strongest impact for the Client, enabling teams to complete these tasks much faster and more efficiently.

 

Two Dimensions of Value: Regulatory Protection and Financial Return

Medea™ delivers transformative benefits across two core dimensions:

  1. Structural MDR Compliance Safeguard
  2. Medea™ transforms technical files from a recurring corporate emergency into a continuous, standard operational state. The platform provides traceable and auditable literature reviews through automated parsing across MEDLINE/PubMed and Embase, eliminating systematic evidence gaps. Built natively around the precise structures required by EU MDR Annex XIV, Medea™ shields organizations against documentation fines of up to €140,000 per violation under D.Lgs. 137/2022, ensuring permanent audit readiness and protecting executive leadership from personal liability exposure.

  4. Measurable Cost Saving from Day One
  5. Medea™ reduces the time compliance teams spend on the research-intensive phase of every CER by up to 70%, recovering 29.4 hours of high-value work on every single report. For a baseline CRO producing two CERs per month, this generates a minimum net annual saving of €16,344 — with the full platform license offset within the very first month of deployment. CROs with higher volumes realise proportionally greater returns: a mid-size CRO producing four CERs per month saves €44,568 per year, while a large CRO at six CERs per month saves €72,792 annually. A detailed breakdown of the ROI model is available at www.hubmed.ch/tools/medea-roi-savings-cro.

 

Validated by Early Adopters: First Clients Successfully Onboarded

Prior to today’s official launch, a select group of CROs and Medical Device manufacturers across Italy and Switzerland have already integrated Medea™ into their core compliance operations. These early partners are actively using the platform to streamline their clinical evaluation processes, validating Medea™’s capacity to deliver immediate operational efficiency and regulatory security in real-world, high-stakes environments. Their experience has directly informed the platform’s feature roadmap and onboarding methodology.

 

The Medea™ Early Adopter Program — Enrollment Closing July 31, 2026

HubMed is offering a limited number of additional seats in its Medea™ Early Adopter Program, open until July 31, 2026. Early Adopters gain preferential access to the platform and a set of exclusive benefits:

  • Direct Product Influence: Work alongside HubMed’s Swiss engineering team to shape the Medea™ roadmap. Specific regulatory challenges become the blueprint for upcoming features.
  • Concierge Onboarding & Support: Dedicated implementation specialists ensure seamless integration with existing data structures and “Secure Vault” requirements.
  • Founding Partner Pricing: Permanent, preferential pricing as a founding member of the HubMed ecosystem — guaranteed protection against future price increases.

To apply or request a demo: www.hubmed.ch/contactus

 

About HubMed Technologies

HubMed Technologies GmbH is a Swiss-incorporated AI software company headquartered in Lugano, Switzerland, focused on transforming R&D workflows across the Medical Device, Nutraceutical, and Cosmetics sectors. Through its Swiss-made platform, HubMed helps scientific and regulatory teams accelerate discovery, automate documentation, and turn complex evidence into structured, audit-ready outputs.

The HubMed platform comprises two integrated solutions:

  • Medea™ (Clinical Compliance), launched today.
  • Designed to guide teams in applying MDR 745 guidelines, Medea™ ensures that clinical evaluation documentation is structured, compliant, and audit-ready. It features automated literature search and evidence synthesis, drastically reducing manual tasks, minimizing transcription errors, and enabling the rapid preparation of final documentation.
  • Adam™ (Preclinical Discovery), currently in development.
  • This solution automates the design, screening, and optimization of novel active molecules. It enables target identification, hit selection, and early risk assessment (toxicity and ADME predictions), resulting in a 10x faster identification of promising active ingredients and a 60–80% reduction in candidate screening costs.

With a privacy-first architecture, enterprise-ready security, and a strong focus on traceability, HubMed enables life science organizations across Europe to reduce time-to-market, improve compliance readiness, and lower R&D costs. The company’s mission is to bring Swiss precision and applied AI to the most demanding scientific and regulatory environments.