Smart Risk
Build Quality Documentation in MINUTES not MONTHS
Revolutionizing ai Risk Management
Join leading consulting firms using SmartRisk
Smart FMEA is an innovative platform that revolutionizes risk management for pharmaceutical and medical device consulting companies. It accelerates hazard identification, provides ISO and FDA compliant mitigations, and generates audit-ready reports. Click below to explore how Smart FMEA can transform your risk management processes.
Key Advantages
Empowering Risk Management
End-to-End Risk & Quality Integration
Smart FMEA connects FMEA, CAPA, and Nonconformance Management in one streamlined platform. When a failure mode is identified, it can be linked directly to corrective actions and tracked through closure—ensuring traceability from risk analysis to resolution.
Faster, Smarter Risk Analysis
AI-assisted suggestions accelerate hazard identification, causes, and mitigations. Consultants can cut FMEA drafting time by 50–70%, focus SME discussions on high-risk issues, and deliver audit-ready reports aligned with ISO 14971, ICH Q9, and 21 CFR 820.
Stronger Compliance & Audit Readiness
With automated traceability, revision history, and one-click export to PDF/CSV, Smart FMEA reduces manual effort, ensures clear links between risks, CAPAs, and nonconformances, and strengthens documentation for regulators and clients.
AI Consultation and Dev
Build AI that ships — and sticks.
Foton helps teams design, build, and deploy AI/ML products that solve real problems, meet regulatory expectations, and scale. We’re the creators of SmartRisk, an AI-powered risk management platform used by regulated teams to move faster with confidence.
What we do
End-to-end AI & ML consulting
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AI product strategy: opportunity mapping, ROI models, data & feasibility assessments.
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ML engineering: model selection, training, evaluation, MLOps, and deployment.
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GenAI apps: RAG systems, copilots, knowledge assistants, safety guardrails.
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Validation & risk: model performance, bias/robustness testing, monitoring, traceability.
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Compliance-ready delivery: documentation, change control, and audit-friendly artifacts.
Why Foton
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Outcomes over hype: measurable impact, not proof-of-concept purgatory.
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From lab to production: modern MLOps, observability, and lifecycle management.
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Built for regulated teams: experience with risk, quality systems, and documentation.
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Makers of SmartRisk: we don’t just advise—we ship products people use.
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Data pipelines: collection, labeling, feature stores, governance.
Our Approach
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Discover: problem framing, data audit, success metrics.
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Design: architecture, model approach, risk & compliance plan.
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Build: sprint development, iterative evaluation, user feedback loops.
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Validate: performance, safety, bias, and reliability testing.
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Deploy & monitor: CI/CD for models, dashboards, alerts, drift & risk monitoring.
About us
Excellence in Risk Management
At Smart FMEA, we help pharma and medical device consulting firms accelerate risk management and deliver stronger outcomes for their clients.
With over 25 years of expertise in regulatory compliance, quality systems, and product risk analysis, our team built Smart FMEA to solve a critical industry challenge: risk assessments take too long, cost too much, and often lack traceability.
Our AI-powered platform streamlines FMEA, CAPA, and nonconformance management in one place. Consultants and quality leaders use Smart FMEA to:
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Draft FMEAs up to 70% faster
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Link risks directly to corrective and preventive actions
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Export audit-ready documentation aligned with ISO 14971, ICH Q9, and 21 CFR 820
We believe in keeping experts in control while letting automation handle the heavy lifting. The result? Smarter risk management, faster compliance, and more value for your clients.
Client Testimonials
“Smart FMEA's platform has significantly enhanced our risk management capabilities, allowing us to streamline processes and improve overall efficiency.”
Dr. Amanda Zhou
“The comprehensive compliance support provided by Smart FMEA has been invaluable in ensuring that our risk management practices are aligned with industry regulations.”
Mark Taylor
“Smart FMEA's ability to generate documentation for small and large companies is a great correlation into larger eQMS systems. Completely changes how documentation is created.”
Dianne A.