Treat or Prevent
Drives therapeutic action — closed-loop insulin dosing, ventilator control.
Award-Winning SaMD Development
What Qualifies as SaMD — Because the Line Matters
Four intended-use categories push software into SaMD territory. Your intended use statement draws the line — not the label.
Diagnose
Identifies disease or injury — AI imaging, arrhythmia and sepsis models.
Monitor
Tracks clinical state for immediate action — real-time deterioration alerts.
Predict
Risk scores that drive decisions — treatment choice, escalation timing.
SaMD Categories We Build
Six categories — each with its own regulatory pathway and clinical-validation requirements.
The Regulatory Pathway — Choosing the Right One Before Development
Most diagnostic AI and CDS is Class II.
Risk Classification First
Risk and seriousness set the class.
510(k) — Substantial Equivalence
Predicate exists — fastest route.
De Novo — Novel Low-to-Moderate Risk
No predicate — FDA sets a new class.
Pre-Submission Meetings
FDA feedback before you build.
Clinical Validation — The Evidence That Makes or Breaks a SaMD Submission
Clinical validation is a study, not testing.
Study Design Matches the Intended Use
Academic-center data may not generalize to the community setting you deploy in.
Performance on the Metrics That Matter Clinically
Sensitivity, specificity and PPV/NPV at realistic prevalence — not raw accuracy.
Subgroup Performance, Not Just Population-Level
FDA expects equitable performance across demographic and clinical subgroups.
Real-World Evidence Supplements Controlled Data
Post-market real-world data weighs heavily for AI/ML products. We build for it.
SaMD Products We've Built and Cleared. What the Submissions Showed.
Each card is a SaMD product we designed and cleared.
Talk to Our TeamDe Novo
AI Diabetic Retinopathy Detection — Ophthalmology diagnostic SaMD. FDA De Novo granted. Sensitivity 91%, specificity 96% in validation study.
510(k)
Cardiac Arrhythmia Detection Algorithm — ECG analysis SaMD. 510(k) cleared first submission. AUC 0.97 across validation dataset.
De Novo
Sepsis Early Warning System — Clinical decision support SaMD. De Novo granted. 40% improvement in early identification vs. standard care.
510(k)
Surgical Implant Planning Software — Orthopedic planning SaMD. 510(k) cleared. Adopted by 3 health systems within 6 months of clearance.
510(k)
Radiology AI — Chest X-Ray Analysis — Diagnostic imaging SaMD. 510(k) cleared. Sensitivity 94.2%, specificity 91.8% on held-out clinical dataset.
De Novo
CGM Data Analysis Software — Remote monitoring SaMD. De Novo granted. Integrated into RPM platform serving 15,000 patients.
How We Build SaMD
Regulatory strategy shapes architecture, validation, and timeline.
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Regulatory Strategy First
Regulatory Strategy First
Intended use, risk class, and pathway — set before design.
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IEC 62304 From the First Sprint
IEC 62304 From the First Sprint
Safety class, plan, design, and testing — integrated, not retrofitted.
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Algorithm Development and Validation in Parallel
Algorithm Development and Validation in Parallel
Study design, IRB prep, and sites run alongside the algorithm.
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Documentation Built for Submission
Documentation Built for Submission
SDD, SBOM, hazard analysis, and PCCP — submission-ready.
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Post-Market Planning Built In
Post-Market Planning Built In
Performance monitoring, adverse events, and PCCP updates.
Compliance & Standards We Treat as Architecture, Not a Checklist
FDA device law, lifecycle standards, and risk management — built in from the start.
FDA Pathways
FDA SaMD & Submission Pathways
SaMD guidance and 510(k) / De Novo / PMA pathways.
Quality
Quality System & Design Controls
Design-control requirements an FDA submission depends on.
Software & Risk
Software Lifecycle, Risk & Usability
Lifecycle process, risk management, usability, and cybersecurity.
Privacy & Security
Privacy, Security & Data Protection
PHI handling, encryption, access controls, and audited security.
Global
Global Market Access
EU MDR Article 22 SaMD provisions plus GDPR compliance.
Interop & Access
Interoperability & Accessibility
Clinical data exchange, imaging, and accessibility.
The Clinical Software You're Building Has a Regulatory Reality. The Sooner You Engage With It, the Better.
Organizations that discover SaMD requirements during development build them in. Those that discover them at launch redesign under pressure and delay market entry. The engagements that go well start with regulatory strategy. Thirty minutes. No pitch.
Book a Discovery Call
Award-Winning AI Development & Consulting
100 Fastest Growth Companies
Global Spring Winner
Top App Development Company
AWS Partner Network
Google Cloud Partner
Highly Rated on Trustpilot
Verified Agency
Top App Development Company
ASSOCHAM Member
Frequently Asked Questions
[ 1 ]
How do we know if our software is SaMD?
Intended use decides it. Analyzing patient data to detect, diagnose, treat, or monitor a condition is SaMD.
[ 2 ]
What's the difference between 510(k) and De Novo for SaMD?
510(k) needs a predicate and is faster. De Novo has none, takes longer, and sets a precedent.
[ 3 ]
How much clinical evidence does FDA require?
Class II 510(k) needs analytical and clinical validation. De Novo needs more. A pre-sub confirms scope.
[ 4 ]
How do you handle AI/ML algorithms that update after clearance?
A Predetermined Change Control Plan covers post-clearance updates. We build PCCP-eligible architectures.
[ 5 ]
How long does SaMD clearance take?
FDA review: 3–12 months for 510(k), 12–24 for De Novo. Build and prep add 6–18 months.
[ 6 ]
Who owns the cleared product?
You do. Full IP transfer at close — code, data infrastructure, validation and submission docs.
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