Quality & Regulatory Systems
The compliance backbone for medical and regulated products — design controls, quality systems, and audit-ready documentation, now accelerated with AI.
What I do
Services
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ISO 13485 Quality Systems
Stand up or improve an eQMS — I've built ISO 13485 quality systems from scratch.
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Design Controls (21 CFR 820.30)
Design inputs and outputs, verification & validation, design transfer, and the traceability that ties them together.
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510(k) & Regulatory Submissions
Documentation and support for Class I & II devices and FDA submissions.
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Risk Management & FMEA
Design, process, and use-related risk analysis per ISO 14971.
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CAPA & Process Improvement
Corrective and preventive action, root-cause analysis, and redesign for quality and cost.
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AI-Accelerated Documentation
Use AI to draft, review, and maintain quality documentation — with a human in the loop and a full audit trail.
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Regulated Software (IEC 62304)
Anthropic's documented AI-native development lifecycle — spec as source of truth, version-controlled artifacts, deterministic gates — implemented and mapped to design-controls-grade traceability for AI and software.
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ISO 9001 & Quality Consulting
Broader quality-system support beyond medical devices.
The bridge
Where regulatory rigor meets AI.
Most AI consultants have never seen a design control or a traceability matrix. I've built the quality systems and the AI — so I can bring AI into a regulated environment in a way auditors and quality teams will actually accept. That combination is rare, and it's the whole point.
Let's find the highest-value thing to automate first.
Book a free opportunity call — we'll find where this would save you the most, then I'll build you a short demo on your own workflow. No pitch, no obligation.
Book a free opportunity call →