SOTA-CER
AI-Powered Global Clinical Evaluation for Medical Devices
Clinical Evaluation for Medical Devices / In Vitro DiagnosticsAI Agent System
From Literatureto Clinical Evidenceto CER Reports
Complete Evidence Trail
Every conclusion starts from the original source, moves through evidence objects, normalized facts, and strategy reasoning, and ends in a reviewable report.
Clinical EvaluationWork Management
Project status, module entry points, and recent activity are shown in one place, so teams can enter CER, SOTA, device evidence, endpoint strategy, and PMS analysis from the same workspace.
SOTA and Device AnalysisRun in Parallel
Move literature evaluation and device evidence through the same module set, reducing the need to switch between spreadsheets, documents, and search records.
Full Traceabilityfor Literature Screening
Keep the key evidence chain for SOTA literature evaluation, from search results and screening stages to inclusion and exclusion reasons, with reviewable statistics.
Analyze LiteratureAgainst Source Text
Experts can review PICO, samples, indications, and safety or performance information alongside the full-text context, keeping structured fields traceable to sources.
Direct Access toClinical Endpoint Traceability
Organize safety and performance measures into endpoint evidence, then develop evidence strength, gaps, and PMCF candidate recommendations.
Post-MarketSurveillance Data
Public PMS, recall, and vigilance records are organized by source, relevance, and risk theme as inputs for PMS/PMCF and CER updates.
Medical Device / IVDRegistration Reports
Every module run preserves sources, status, and human review cues, then generates downloadable outputs.
Save Expert Timefor Judgment
SOTA-CER advances repetitive search, screening, extraction, and draft preparation; experts focus on key judgment, clinical rationale, and final confirmation.
MultipleUse Scenarios
Cover typical clinical evaluation workflows across manufacturer registration, regulatory consulting delivery, post-market surveillance, and medical writing.
Regulatory Affairs Teams
For submissions, reviewer responses, and launch materials, supporting CER, CEP, and equivalence assessment outputs.
Regulatory Consulting Teams
For multi-client delivery, turning search, screening, evidence analysis, and reports into reusable workflows.
Clinical R&D Teams
For SOTA, endpoint, benefit-risk, and PMCF strategy decisions, identifying evidence strength and clinical gaps early.
Medical Writing Teams
For external strategy narratives, section drafting, and reviewer communication support based on traceable evidence.
Flexible Choicesfor Different Needs
From online trials and expert collaboration to dedicated cloud and enterprise network deployment, SOTA-CER can match each team’s data security, delivery depth, and project scale.
SaaS Online
Open an online workspace by project to quickly try SOTA, endpoint, PMS, and evidence package export workflows.
SaaS + Expert Support
Pair the online system with clinical evaluation, regulatory, and medical writing experts for projects that need delivery support.
Private Cloud Deployment
Deploy in a customer-dedicated cloud environment with data isolation, permission management, and multi-team collaboration.
On-Premises Deployment
Deploy inside an enterprise network or controlled infrastructure for strict data security and compliance governance needs.
Contact Us
We will follow up by email or another suitable channel to confirm your needs and arrange a product demo or technical discussion.
You can email us directly with a brief note about your team, device area, focus module, or business need.