About Deicell Systems

Your science is moving fast. Auditors do not wait.DeiCell Systems builds lean, audit-ready compliance systems for life-science innovators before the auditors show up.We help founders design and deploy regulatory and quality infrastructure that grows with their organization and holds up under the toughest scrutiny, whether from the FDA, CE Mark reviewers, or investors. Our work turns regulatory pressure into clear, controlled systems that free you to focus on discovery!

To learn more about how we can help:

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Who We Serve

We work with:

1. Biotech and MedTech startups
2. AI-driven health and digital therapeutic developers
3. Diagnostics and cell-therapy teams

Whether you are just forming your first processes or preparing for an inspection, DeiCell meets you where you are and helps you move forward with structure and confidence.

Built for Innovators

DeiCell Systems combines regulatory science, quality engineering, and AI-driven insight to help life science startups reach audit readiness faster and with greater precision.

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Core Services

1. Regulatory Strategy and Readiness
• FDA, EMA, and CE Mark pathway planning
• Gap assessments and pre-submission preparation
• Market-entry strategies for U.S. and international expansion2. Foundational Quality Systems
• CAPA, Change Control, Document Control, and Internal Audit setup
• SOP drafting, control, and version tracking
• Training and competency record design3. QMS and SOP Development
• ISO 13485 and GxP compliant architectures
• 21 CFR Part 11 validation readiness
• End-to-end QMS lifecycle planning4. Tech-Enabled Optimization
• AI-powered review for CoAs, IFUs, UDIs, and PMS data
• Digital QMS integration and eQMS validation
• Supplier control and risk-management automation