MEDEA®: The Workflow Engine for Regulatory Excellence.
Stop managing compliance through fragmented tools. Medea is the central cockpit that orchestrates your technical documentation, evidence appraisal, and audit readiness in one unified digital workflow.
Bridge the "Fragmentation Gap" to Audit-Proof Success Body
Under MDR and IVDR, the quality of your technical documentation determines your market access. Medea addresses the core issues identified by Notified Bodies to prevent multi-million euro delays.
Automated Completeness Checks
75% of submissions are flagged as incomplete by Notified Bodies. Medea acts as a pre-reviewer to ensure your file is 100% compliant before the clock stops.
Eliminating Rework & Non-Conformities
Reduce "Rounds of Questions" (RsQs) and eliminate Major NCs by automating State of the Art (SOTA) and Systematic Literature Reviews (SLR)
Audit-Ready Traceability
Move beyond Excel and Word. Every line of your CER is linked to evidence with a digital audit trail that satisfies Notified Body and FDA scrutiny
Precision Methodology, Automated Workflow
PICO-Driven Literature Surveillance
Machine-read PubMed, Embase, and specialized databases to find, appraise, and extract clinical data with scientific rigor.
Automated SOTA & CER Analysis
Master the "State of the Art" requirements with automated benchmarking and comparative effectiveness research.
Annex I GSPR Mapping
Automatically map your clinical evidence to General Safety and Performance Requirements (GSPRs) for seamless technical file integration.
2025/2026 Readiness
Manage the mandatory EUDAMED rollout and new supply interruption obligations (MDCG 2024-16) while protecting legacy device transitions.
Targeted Solutions for CROs and MedTech
Contract Research Organization (CRO)
Boost profitability and operational speed. Deliver gap-free submissions that pass the NB Completeness Check on the first attempt, protecting your clients' timelines.
Medical Device Manufacturers
Protect your revenue. Every month of delay in certification equals €500K–€2M in lost market opportunity. Medea ensures your Class IIb and III devices stay on the market.
Frequently asked questions
Here are some common questions about Medea.
Medea ensures that technical documentation mirrors the internal review standards of Notified Bodies by automating the completeness check and utilizing the PICO framework, which leads to higher submission quality and faster approval.
Yes. Medea includes dedicated modules for mandatory EUDAMED electronic system registrations and manages the complex transition periods for legacy devices (up to 2027/2029) to ensure continuous market availability.
The system maintains a locked version history and an end-to-end audit trail. If an auditor asks for the source of a specific claim, Medea provides the exact scientific paper, the appraisal criteria, and the electronic signature in seconds.
Ready to Ensure Compliance?
Join the future of regulatory excellence and stop fearing your next audit.