The Engine for First-Time-Right Regulatory Submissions
Transform your CRO from "chasing documents" to delivering guaranteed compliance. Medea eliminates the 30% rejection rate of CERs by automating completeness checks and literature surveillance. Reduce "Rounds of Questions" (RsQs) and boost your operational profitability with the industry's most advanced AI for MDR/IVDR clinical evidence.
Resolving the Submission Quality Crisis for Your Clients
In an era where 75% of submissions are flagged as incomplete by Notified Bodies, your reputation depends on submission quality. Medea shifts the burden from manual labor to automated precision.
Eliminating Rework & NCs
Stop the cycle of audit non-conformities and rework that erodes project margins.
NB-Ready Documentation
Deliver technical files that mirror the internal review standards of Notified Bodies, ensuring a smooth path through the completeness check.
Audit-Proof Data Continuity
Move beyond fragmented Excel and Word files to a single, traceable "Evidence Vault" that satisfies even the most rigorous auditor.
Precision Tool for High-Performance CROs
Medea | Clinical Evaluation Automation
Automated Completeness Check:
Pre-screen submissions to ensure all Annex II and III requirements are addressed before they reach the Notified Body.
PICO-Driven SLR & SOTA:
Automate Systematic Literature Reviews and State of the Art analysis with absolute scientific rigor and 70% less manual effort..
Ensuring Compliance. Enhancing Profitability.
Medea isn't just a compliance tool; it is a strategic asset that allows your CRO to scale without increasing headcount:
Reduce Time-to-Submission: Cut document preparation time by 70%, moving from weeks to days.
Justify Value to Clients: Provide a clear ROI by preventing certification delays that cost between €500K–€2M per month in lost revenue for your clients.
Swiss Precision & Security: Safeguard sensitive client IP in a secure "Swiss Vault" that meets the highest global data privacy standards.
Frequently asked questions
Here are some common questions about CRO Operational Excellence.
Medea utilizes the PICO framework and automated completeness checks to ensure that submissions are structured exactly how NB reviewers expect, significantly reducing the likelihood of clarifying questions and submission "clock-stops."
Yes. The platform is built for scalability, allowing CROs to manage complex portfolios across Nutraceuticals, Cosmetics, and all Medical Device risk classes (from Class I to III).
Absolutely. Medea automates requirements for mandatory EUDAMED modules and new supply interruption notifications (MDCG 2024-16), while managing legacy device transitions through 2029.
Ready to Scale Your Regulatory Services?
Join the leading CROs who are leveraging AI to deliver audit-proof excellence and unmatched operational speed.