Technical Documentation With Substance, Not Just Volume
Adequacy — internal consistency, responsiveness to the exact guidance FDA published — is what clears a submission without an AI request. Not page count.
The Product Was Fine. The Submission Wasn't.
Weak documentation or a flawed predicate means months of AI cycles on a product that should have cleared. We support 510(k), De Novo, and PMA submissions for SaMD.
Talk to Us About Your Regulatory PathwayTrusted by startups and global leaders
FDA Software Submissions Are Their Own Problem — Not Hardware, Not Just Development
Teams new to FDA software submissions produce packages complete in volume and incomplete in substance. Four areas decide whether you clear or sit in AI cycles for eight months.
Clinical Evidence That Matches What FDA Asked For
The nuance isn't visible from the guidance documents alone. It becomes visible when FDA's AI request asks for exactly what your submission didn't include.
Predicate Analysis That Survives Substantial-Equivalence Review
Wrong predicate = Not Substantially Equivalent determination = back to the beginning. A months-long detour discovered at the worst possible time.
Regulatory Strategy Everything Else Depends On
Pathway, predicate, intended use framing, pre-sub timing. Getting strategy right is worth more than any amount of work on documents built on a flawed foundation.
The Three Pathways
Which pathway applies depends on intended use, risk classification, and whether a legally marketed predicate exists. We work through it during discovery — before development begins.
510(k) — Substantial Equivalence
Requires a predicate with the same intended use. Wrong predicate = Not Substantially Equivalent determination. Review: three to twelve months.
De Novo — Novel Device Classification
For novel products with no predicate. FDA establishes a new classification and clears the product at once — the De Novo becomes the predicate competitors cite. Review: twelve to twenty-four months.
PMA — Premarket Approval
For Class III devices where general controls aren't sufficient. Requires clinical trial data. Most SaMD is Class II — but life-sustaining and novel high-risk uses can reach it.
Where We Support the Regulatory Process
Built during development. Not reconstructed at submission time.
Regulatory Programs We've Supported. The Pathway and the Outcome.
Each card is a clinical software product we carried through FDA review — with the pathway taken and the outcome that followed. Click through to see the program behind each result.
Talk to Us About Your Regulatory PathwayDe Novo
AI Diabetic Retinopathy Detection — Granted. First De Novo in category. Became the predicate for 3 subsequent 510(k)s.
510(k)
Cardiac Arrhythmia Detection Algorithm — Cleared first submission. No additional-information letter. 4-month review.
De Novo
Sepsis Early Warning System — Granted. Pre-submission meeting identified an evidence gap that would have triggered an AI letter.
510(k)
Surgical Implant Planning Software — Cleared first submission. Predicate strategy developed during discovery — 2 alternatives considered and rejected.
510(k)
Radiology AI — Chest X-Ray Analysis — Cleared. Subgroup performance data proactively included — no equity-related AI letter.
De Novo
Remote CGM Analysis Software — Granted. PCCP submitted and accepted — first algorithm update deployed 4 months post-clearance under the PCCP.
510(k)
Clinical Decision Support — Sepsis — Cleared after one AI letter. Response resolved all open questions in a single round.
What We Are — And What We're Not
A software org with deep regulatory context — not a substitute for qualified regulatory affairs professionals.
Not a Regulatory Affairs Consultancy
A Software Org With Regulatory Context
We Work Alongside Your RA Team
No In-House RA? We Connect You
The Frameworks a Submission Is Built Against
FDA clearance spans device law, software lifecycle standards, clinical risk management, and post-market obligations — scoped during discovery, not reconstructed at submission time.
FDA Pathways
Submission Pathways & Digital Health
The FDA framework that governs whether and how a clinical software product reaches market — the three clearance pathways, the AI/ML action plan, the PCCP, and engagement with the Digital Health Center of Excellence.
Software Docs
Software Documentation Guidance
The document set FDA expects in a SaMD or device-software submission — produced during development to submission-ready standards.
Software & Risk
Software Lifecycle, Risk & Usability
The engineering standards that make a submission clearable — lifecycle processes by safety class, clinical risk management, usability engineering, and cybersecurity to current FDA expectations.
Quality
Quality System & Post-Market
The quality-management and post-market reporting requirements a submission and ongoing manufacture depend on.
Privacy & Security
Privacy, Security & Data Protection
PHI handling, encryption, access controls, audit logging, and independently audited security for every component that touches patient data.
Global
Global Market Access
EU MDR Article 22 SaMD provisions and GDPR for organizations bringing clinical software to the European market alongside FDA clearance.
Regulatory Strategy Is a Product Decision, Not a Submission Decision.
Clear on first submission or eighteen months late — the difference is when you engaged regulatory strategy. Thirty minutes. No pitch.
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Frequently Asked Questions
[ 1 ]
When should we start thinking about the regulatory pathway?
Before development begins — ideally before the intended-use statement is finalized. Classification shapes IEC 62304 safety class, validation study design, and documentation scope. Engaging it late means the same decisions with less flexibility and more cost to change course.
[ 2 ]
How do we know which pathway applies to our product?
It depends on intended use, the risk classification that maps to, and whether a predicate exists. This has a specific answer — we work through it during discovery. Near-boundary products require regulatory judgment, not a read of the guidance documents.
[ 3 ]
What does an additional-information request mean and how serious is it?
An AI letter means FDA has questions before it can make a clearance decision — not a rejection. Most resolve with a well-prepared response. The ones that don't reveal fundamental evidence gaps that are almost always preventable with better pre-submission prep.
[ 4 ]
How long does the full process take from development start to clearance?
Development and submission prep: six to eighteen months. FDA review: three to twelve months for 510(k), twelve to twenty-four for De Novo. Total: twelve to thirty months. Planning for the short end and hitting the long end is the most common source of submission-quality pressure.
[ 5 ]
Do we need a pre-submission meeting with FDA?
Not always — but more often than most teams pursue one. Most valuable for De Novo, complex intended-use questions, and uncertain evidence design. Takes two to three months to arrange; the written feedback is consistently worth it.
[ 6 ]
What happens to the regulatory documentation after clearance?
It becomes your post-market regulatory record — the baseline for evaluating software changes, the reference for adverse-event investigations, and what FDA reviews on inspection. We maintain it as a living record, not an archived submission package.
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