Medical Device TIC
ISO 13485. 21 CFR 820. EU MDR. The most demanding device compliance environment — ready.
Purpose-built for medical device testing labs and Notified Bodies. Complete ISO 13485 quality management, EU MDR technical file documentation, 21 CFR 820 QSR compliance, and AI-assisted review — built for the highest-stakes compliance environment in regulated industry.
Built for Medical Device TIC
Every capability is purpose-built for your compliance environment — not adapted from a generic platform.
ISO 13485 Quality Management
Full QMS for medical device manufacturers — design controls, risk management, nonconformance, CAPA, supplier qualification, and internal audit under ISO 13485.
EU MDR Technical File
Structured technical documentation management for EU MDR/IVDR compliance — clinical evaluation, performance evaluation, labeling, and post-market surveillance.
Risk Management (ISO 14971)
Risk analysis, risk evaluation, risk control, and residual risk documentation per ISO 14971. Risk files linked to design records and test results.
Biocompatibility & Performance Testing
ISO 10993 biocompatibility test management, performance testing protocols, and results documentation linked to technical file sections.
Design Control Documentation
Design inputs, outputs, verification, validation, reviews, and transfer documentation — all version-controlled with electronic signatures and audit trail.
Post-Market Surveillance
Complaint management, vigilance reporting, post-market clinical follow-up (PMCF), and periodic safety update report (PSUR) management.
Purpose-built agents for Medical Device TIC
Each agent operates on your live lab data, scoped to one specific job. Not a generic assistant.
Risk Management Assistant
Guides ISO 14971 risk analysis — identifies hazardous situations, estimates probability and severity, and suggests risk control measures based on your device type.
Regulatory Intelligence Agent
Monitors FDA, MDR, and ISO updates affecting your device classifications. Alerts when guidance changes require technical file or QMS updates.
SOP AI Generator
Drafts ISO 13485-compliant procedures referencing specific clause requirements, device classification considerations, and applicable harmonized standards.
Launching Q4 2026 — contact for early access and requirements input
One platform. Your vertical. Ready today.
AILS is already live in Medical Device TIC environments. Every workflow, every compliance framework, every AI agent — deployed and tested. Zero architectural changes needed to go live.