Lean Compliance Systems for Biotech, MedTech, and AI Health Startups
Scalable QMS infrastructure, FDA/ISO alignment, and document control strategies for early-stage innovators.
🔍 Regulatory Document Review
• Labeling, CoA, IFU audits
• FDA, ISO 13485, EU MDR ready
• Traceable, submit-ready feedback
📐 QMS Architecture & Implementation
• Tiered QMS for FDA/CE/Investors
• SOP builds & audit prep
• Scalable, risk-based systems
🤖 NLP-Powered Quality Review
• AI postmarket surveillance
• Automated QC for IFUs, UDIs, PMS
• Rapid, data-driven insights
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Registered in the State of Ohio.
© 2025 DeiCell Systems LLC. All rights reserved.
Site content is proprietary and may not be copied, reproduced, or redistributed without written permission.
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Site content is proprietary and may not be copied...
Registered in the State of Ohio.
© 2025 DeiCell Systems LLC. All rights reserved.
Site content is proprietary and may not be copied, reproduced, or redistributed without written permission.
