Systematic Literature Review & SOTA:
Scientific Precision by Design.
Stop risking Notified Body rejections due to fragmented literature or weak benchmarking. Medea automates the most high-stakes sections of your Clinical Evaluation Report (CER)—the State of the Art (SOTA) and Systematic Literature Review (SLR)—ensuring every claim is audit-proof and scientifically defensible.
Solving the Core Causes of Regulatory RejectionBody
Regulatory professionals know that a CER is only as strong as its foundation. Poor quality clinical data and documentation gaps are primary drivers of certification delays. Medea automates the rigorous methodology required to pass scrutiny
Automated State of the Art (SOTA)
Master the benchmark. Medea identifies and analyzes comparators and current clinical standards automatically, ensuring your device is appraised against the true State of the Art.
Bias-Free Systematic Literature Reviews (SLR)
Move beyond simple searches. Our AI follows strict scientific protocols (PRISMA/Cochrane) to find, filter, and extract data from PubMed and Embase without human "reading fatigue".
Eliminating the 30% Rejection Rate
By automating the completeness check and ensuring data continuity, we address the specific technical documentation failures that lead to 75% of submissions being flagged as incomplete.
From Raw Data to NB-Ready Documentation
PICO-Structured Queries
Ensure your literature searches are targeted and objective using the industry-standard PICO framework.
Dynamic GSPR Mapping
Link clinical evidence directly to your General Safety and Performance Requirements (GSPR) to prove safety and performance requirements are met.
Automated Evidence Appraisal
Digitally score and weight scientific evidence to ensure only high-quality data informs your CER conclusions.
Real-Time CER Updates
As new literature is published, Medea triggers alerts to keep your SOTA analysis and Clinical Evaluation current for the entire product lifecycle.
"Right-First-Time" Methodology
Every month your device is delayed in certification translates to €500K–€2M in lost revenue. Medea doesn't just write reports; it builds a defensible scientific argument that mirrors the internal checklists used by Notified Body reviewers.
1
Reduce Rounds of Questions (RsQs)
High-quality, structured submissions lead to fewer clarifications.
2
100% Traceability
Instantly show an auditor the source, version, and appraisal of any claim in your technical file.
Frequently asked questions
Here are some common questions about SOTA & CER.
Notified Bodies use the SOTA section to determine if your device is still a safe and effective option compared to current clinical standards. Medea automates this benchmarking to ensure your device is always positioned correctly.
By automating the Systematic Literature Review through the PICO framework, Medea ensures that search criteria are pre-defined and transparent, eliminating the selection bias that often leads to audit findings.
Yes. Medea generates structured, high-quality documentation designed to pass the Administrative and Completeness Check performed by Notified Bodies on the first attempt.
Secure Your Market Access
Don't let a documentation gap block your product. Automate your CER and SOTA with the precision of Swiss AI.