HubMed™ & Medea™ Media Kit

For immediate media use

Milan, ITALY | 6 October 2026

HubMed introduces an AI-assisted approach to regulatory compliance

HubMed Technologies GmbH is a Swiss Life Sciences software company building a unified AI platform for scientific discovery and regulatory compliance. The platform brings together two complementary solutions: Adam™, which is being developed for in-silico preclinical discovery, and Medea™, the clinical-compliance solution already available to the market.

HubMed launched Medea™ on 21 June 2026 in response to a clear market need: for Medical Device companies, regulatory and compliance work is no longer a final check before market entry. It is becoming a core capability that must be considered throughout the product lifecycle, from evidence planning and clinical evaluation to market access and post-market maintenance.

Medea™ is designed for Regulatory Affairs, Clinical Evaluation, Quality and Compliance teams at Medical Device manufacturers, as well as Contract Research Organisations (CROs). It supports research-intensive Clinical Evaluation Report (CER) workflows under Regulation (EU) 2017/745, including systematic literature research, evidence appraisal, State of the Art analysis, structured documentation and traceable maintenance of the evidence base.

Since its launch, Medea™ has generated strong interest among its target audience, particularly Medical Device regulatory and compliance teams looking for more structured, transparent and scalable ways to manage clinical-evidence workflows. The product is now commercially available as a cloud-based SaaS solution.

The core story: Assisted AI, not AI-driven compliance

Medea™ is an AI-assisted workspace for regulatory experts. It is designed to accelerate research-intensive work while keeping qualified professionals in control of every scientific, regulatory and approval decision.

In Life Sciences, speed has value only when it is paired with traceability, reproducibility and accountability. An auditor reviewing a CER needs to understand the source of a clinical claim, the search strategy used to identify evidence, the appraisal criteria applied and the rationale behind the final conclusion. An autonomous or black-box approach to AI does not adequately address these requirements.

For this reason, HubMed positions Medea™ as AI-assisted, rather than AI-driven. Medea™ can help teams carry out labour-intensive tasks such as semantic literature searching, screening large volumes of abstracts, parsing datasets, organising evidence and preparing structured drafts. The qualified professional remains responsible for reviewing, editing, accepting or rejecting outputs and for making the final scientific and regulatory judgement.

This human-in-the-loop model reflects a different view of innovation in regulated environments:

Digital Quality → Controlled Quality → Traceable Quality → Reproducible Quality → AI-Assisted Quality

The objective is not to automate accountability away. It is to give specialists more time for the work that requires their expertise: clinical appraisal, benefit-risk reasoning, quality oversight, strategic regulatory planning and patient safety.

Why regulatory compliance is becoming a strategic priority

Under the EU Medical Device Regulation, demonstrating conformity with the relevant General Safety and Performance Requirements includes a clinical evaluation. Annex XIV sets out the requirements for clinical evaluation and post-market clinical follow-up.

For manufacturers, this makes clinical evidence, documentation discipline and change traceability central to market access and lifecycle management. Regulatory expectations increasingly influence how Medical Device organisations plan products, organise data, assess evidence, prepare technical documentation and maintain their dossiers after launch.

HubMed's view is that compliance should not be treated as an isolated late-stage activity. When evidence and documentation workflows are designed early, they can reduce avoidable rework, help teams identify gaps sooner and support more predictable go-to-market decisions. Medea™ is built to support this compliance-by-design approach without removing the oversight of trained professionals.

What Medea™ does

Medea™ supports the research-intensive elements of clinical evaluation in a single, structured workspace. It is designed to help teams define and document literature searches, organise screening and appraisal work, map evidence, maintain traceable links to source material and prepare documentation aligned with the clinical-evaluation structure expected under EU MDR Annex XIV.

The platform records the workflow context behind outputs, including search strategies, filters and appraisal parameters. It is intended to make the route from source evidence to a documented conclusion clearer and easier to review. Medea™ does not replace qualified regulatory or clinical professionals, and it does not make final decisions independently.

Depending on workflow scope, document complexity and team maturity, Medea™ can help reduce research-intensive CER work by up to 70%. This is an efficiency claim concerning the research, screening, appraisal and drafting burden; it is not a substitute for expert review, legal interpretation or regulatory decision-making.

The HubMed platform: from discovery to compliance

HubMed is developing an integrated platform across the Life Sciences R&D lifecycle. Medea™ is the commercial solution focused on clinical evaluation and regulatory-compliance workflows for Medical Devices. Adam™, currently in development, is intended to support in-silico discovery, screening and optimisation of promising active molecules.

The platform strategy is to reduce fragmentation between scientific discovery, evidence generation and regulatory readiness. Rather than treating these as disconnected phases, HubMed aims to create continuity between the data, rationale and decisions that support a product from early research to market-facing documentation.

Medea™ at CPHI Milan

HubMed will present Medea™ at CPHI Milan, 6–8 October 2026, where attendees will be able to request a personalised demonstration of the platform. The company will also contribute to the wider discussion around pharma-grade discipline, clinical evidence, regulatory readiness and scalable compliance processes for Life Sciences organisations.

The CPHI presence supports HubMed's current commercial focus: demonstrating how an AI-assisted, human-controlled approach can help Medical Device teams make regulatory work more efficient without compromising scientific accountability.

Early Adopter Program: extended through October

To coincide with CPHI Milan and the first phase of commercial market engagement, HubMed has extended the Medea™ Early Adopter Program through October 2026.

The program is intended for selected Medical Device manufacturers and CROs that want to evaluate Medea™ in a real-world workflow, receive tailored onboarding and contribute practical feedback to the product roadmap. Participants can explore how the platform fits into their existing evidence and documentation processes while engaging directly with the HubMed team.

The initiative builds on the early market interest generated after Medea™'s June launch and reflects HubMed's commitment to developing the product in close dialogue with the professionals who use it.

Referral Program for partners

HubMed has also introduced a Referral Program for partners who wish to introduce Medea™ to relevant clients in the Medical Device and CRO ecosystem.

The program is designed for organisations and advisers with trusted relationships across regulatory affairs, quality, clinical evaluation, market access and Life Sciences consulting. It provides a structured route for partners to connect eligible clients with HubMed for an initial discussion or personalised Medea™ demonstration.

Details of the Early Adopter and Referral Programs, including eligibility and commercial terms, are available from HubMed on request.

Media fact sheet

Approved spokesperson quote

Boilerplates for editorial use

50-word company boilerplate

HubMed Technologies GmbH is a Swiss Life Sciences software company headquartered in Lugano. Its HubMed™ platform brings together AI-enabled solutions for scientific discovery and regulatory compliance. Medea™, the company's commercial solution, is an AI-assisted workspace for Medical Device clinical evaluation, evidence appraisal and structured CER documentation under EU MDR.

100-word Medea™ boilerplate

Medea™ is HubMed's AI-assisted workspace for Medical Device regulatory and clinical-evaluation teams. It supports systematic literature research, evidence appraisal, State of the Art analysis and structured Clinical Evaluation Report workflows under EU MDR 2017/745. Medea™ is designed around a human-in-the-loop model: AI helps accelerate research-intensive tasks, while qualified professionals retain full responsibility for reviewing evidence, making judgements and approving documentation. The platform focuses on traceability and reproducibility, helping teams connect outputs to source evidence and maintain a clear digital record of key workflow decisions. Medea™ launched commercially on 21 June 2026.

Suggested media angles

• How Medical Device compliance is shifting from a late-stage documentation exercise to a strategic, lifecycle-wide capability.
• The distinction between AI-assisted and AI-driven systems in highly regulated environments, where trust depends on human oversight, evidence traceability and reproducibility.
• The growing need for digital workflows that can support regulatory teams and CROs facing heavier documentation workloads under EU MDR.

Notes for editors

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. Any time-reduction figure refers to research-intensive workflow activities and depends on the scope, complexity and maturity of the organisation's process.