Your Always-On AI Auditor.
Pre-check your technical files and quality records with AI before the real auditor arrives. Identify gaps in seconds.
Gap Detection
AI scans your technical documentation to identify missing requirements against MDR and FDA regulations.
Consistency Check
Ensure consistency across IFUs, Risk Assessments, and Clinical Evaluation Reports automatically.
Mock Audit Simulator
Practice answering auditor questions generated based on your specific device classification and documentation.
Automated Audit Readiness
Upload & Index
Securely upload your QMS documents (PDF, Word). Our system indexes and understands the context of your technical files.
AI Analysis
The AI cross-references your files against specific regulation checklists (e.g., EU MDR Annex I) to find non-conformities.
Actionable Report
Receive a prioritized list of gaps and suggested fixes. Fix them before the real auditor walks in.