Medea™ Early Adopter Program
Shape the Future of AI-Assisted Clinical Compliance.
Join the Medea Early Adopter Program and gain exclusive access to Swiss-engineered, AI-assisted workflows for MDR/IVDR compliance. Be the first to reduce your documentation workload by up to 70%.
EA Program will expire on November 30, 2026
The Reality Check
The Anatomy of an Audit Failure
Audit Failure is Built Over Time—Not Found by Surprise.
Non-compliance is rarely a sudden event. It is the result of a progressive degradation of documentary processes that occurs when organizations attempt to manage MDR complexity with tools designed for the pre-2025 world.
1
Fragmented Clinical Evidence:
Data scattered across Word, Excel, and shared folders.
2
Untraceable Literature Review:
Non-reproducible methodology loses Notified Body trust.
3
The "Manual Rework" Trap:
Weeks of manual updates for every minor device change.
4
The Consolidated Gap:
Impossible to close under audit pressure; Major Non-Conformity becomes a certainty.
The Solution
Medea™: Transforming Fragile Processes into Competitive Advantages
Within the HubMed™ platform, Medea™ is the dedicated module for clinical and regulatory excellence. Designed specifically for EU MDR Clinical Evaluation, it replaces the fragility of manual labor with a robust, Swiss-made digital infrastructure.
"Medea™ does not replace regulatory expertise. It amplifies it — precisely when regulation becomes more demanding."
Why Medea™ is Different:
Expert-First Automation:
Medea™ doesn't replace your team’s scientific judgment; it protects it from administrative fatigue and makes your expertise scalable.
Structural Infrastructure:
From AI-assisted literature screening to structured CER drafting and post-market surveillance integration, Medea™ provides the audit trail required by modern MDR standards.
Future-Proof Compliance:
Transition from "Emergency Audits" to "Audit Readiness" as a standard operational state.
The Partnership
More Than a Pilot. A Strategic Partnership.
While others wait for standard releases, our Early Adopters gain a significant competitive advantage by integrating Medea into their core R&D and Regulatory workflows today.
Direct Product Influence
Work alongside our Swiss engineering team to customize the Medea roadmap. Your specific regulatory challenges become the blueprint for our next features.
Concierge Onboarding & Support
Receive "white-glove" service with dedicated implementation specialists to ensure Medea integrates seamlessly with your existing data structures and "Secure Vault" requirements.
Founding Partner Pricing
Secure permanent, preferential pricing as a founding member of the HubMed ecosystem—guaranteed protection against future price increases.
Eligibility
Who Should Apply?
We are looking for forward-thinking organizations that value scientific rigor and are ready to lead the industry transition to AI-assisted compliance.
Sectors
Medical Device Manufacturers (Class IIa, IIb, III) or innovative CROs.
Focus
Teams looking to automate PICO-driven literature reviews and Technical File generation.
Mindset
Organizations committed to "First-Time-Right" regulatory submissions.
Application Deadline
Enrollment for the exclusive Medea Early Adopter Program closes on November 30, 2026.
How it works
Your Journey to 70% Greater Efficiency
Selection & Scoping (Week 1-2)
We conduct a deep dive into your current CER/Technical File workflow to identify the biggest bottlenecks.
Guided Implementation (Month 1-3)
Your team begins using Medea on a live project with dedicated weekly support from our regulatory scientists.
Optimization & Validation
We quantify your time savings (target: -70%) and refine the AI outputs to ensure they meet your specific Notified Body expectations.