MEDEA™: The Workflow Engine for Regulatory Excellence.
Stop managing compliance through fragmented tools. Medea™ is the AI-assisted workspace that orchestrates your regulatory documentation, evidence appraisal, and CERs in one unified, human-in-the-loop workflow.
Bridge the "Fragmentation Gap" to Audit-Proof Success
Under EU MDR and IVDR, the quality of your CER and technical documentation determines your market access. Medea addresses the core issues identified by Notified Bodies to prevent multi-million euro delays.
EU MDR Completeness Checks:
75% of submissions are flagged as incomplete by Notified Bodies. Medea acts as a pre-reviewer to ensure your CER and technical file are 100% compliant before the clock stops.
Reducing Rework & Non-Conformities
Reduce 'Rounds of Questions' (RAQs) and eliminate Major NCs by streamlining State of the Art (SOTA) and Systematic Literature Reviews (SLR) for your CER.
Traceable & Reproducible Evidence
Move beyond Excel and Word. Every line of your EU MDR CER is tethered to source literature with a deterministic digital audit trail, ensuring your AI outputs are defensible, transparent, and auditor-ready.
Precision Methodology, AI-Assisted Workflow
PICO-Driven Literature Surveillance
AI-Assisted Literature Screening: Machine-read PubMed and specialized online databases to parse clinical data with scientific rigor—keeping senior experts in full control of inclusion and appraisal decisions.
Source-Tethered SOTA & CER Analysis
Align with EU MDR Annex XIV requirements through automated benchmarking, where every finding links directly back to raw source data.
Annex I GSPR Mapping
Map your clinical evidence to General Safety and Performance Requirements with AI-suggested links your experts review and approve
2026/2027 Readiness
Manage the mandatory EUDAMED rollout and new supply interruption obligations (MDCG 2024-16) while protecting legacy device transitions.
Operational Efficiency & ROI
70% Time Reduction
Reduce the time spent on literature screening and appraisal from an average of 42 hours down to 12.6 hours per CER under EU MDR.
About 29 Hours Saved per CER
For a standard baseline of just 2 CERs per month, that is nearly 60 hours of specialist time recovered every month.
Opportunity Cost Protection
Every month of delay in certification costs up to €250k in lost market opportunities. Medea ensures predictable timelines for faster market access.
Want to calculate your exact savings?
Targeted Solutions for CROs and MedTech
Contract Research Organization (CRO)
Boost profit margins per project and eliminate unbillable manual hours. Deliver gap-free submissions that pass the NB Completeness Check on the first attempt, protecting your clients' timelines.
Explore CRO savings & ROI Metrics
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.
Most teams are fully onboarded within 2 weeks. Because Medea cuts the research-intensive phase of each CER by up to 70%, about 29 hours per report, most teams see a return within their first few CERs.
Ready to Ensure Compliance?
Join the future of regulatory excellence and stop fearing your next audit.