510(k) Submissions
Predicate device selection, substantial equivalence argumentation, and complete technical documentation — structured to the FDA's current submission guidance and ready for eCopy upload.
510(k)Substantial EquivalenceeCopy
FDA 510(k)De NovoISO 1497121 CFR Part 820FDA AI/ML 2021PCCP
FDA Regulatory Experts for Software & AI/ML Devices
We specialize in 510(k) submissions, De Novo classification, and FDA AI/ML compliance for medical device software teams — from regulatory strategy through clearance.
- >40%of 510(k)s receive Additional Information requestsMost are preventable with the right pre-submission documentation strategy.
- 2–3×longer review cycles for AI/ML SaMD without PCCPA documented change control plan keeps your model pipeline moving post-clearance.
- Day 1is when regulatory architecture should startRetrofitting compliance at submission adds months. We build it in from the start.
What We Cover
From Strategy to Cleared
510(k), De Novo, AI/ML, risk management — the full regulatory toolkit, built into your development process from day one.
AI/ML & PCCP Submissions
De Novo classification requests and Predetermined Change Control Plans for AI/ML SaMD — documenting your model update pipeline in a format FDA reviewers expect.
De NovoPCCPSaMD Class II
Regulatory Strategy & Pre-Subs
Early-stage pathway analysis and pre-submission meeting preparation — so you know your clearance route, timeline, and documentation requirements before writing a single test report.
Q-SubPre-SubPathway Analysis
Gap Assessment & Document Review
Independent review of your software documentation against IEC 62304, ISO 14971, and FDA guidance — before FDA sees it. We identify gaps and tell you exactly how to close them.
IEC 62304ISO 14971Second Opinion
Risk Management Files
ISO 14971 risk file development from hazard identification through residual risk acceptance — a living artifact updated throughout development, not assembled at the end.
ISO 14971FMEARisk Controls
Post-Market & Ongoing Support
Post-market surveillance protocols, FDA Additional Information (AI) responses, and ongoing regulatory support as your device evolves and your software updates.
Post-MarketRAI ResponseChange Control
Our Approach
Compliance Built In, Not Bolted On
Regulatory work done at the end of development adds months and risk. We integrate compliance into your SDLC from the first sprint.
510(k) cleared on the first cycle
Most rejections are documentation failures, not device failures. We build the submission package the same way we build software — traceably, from requirements.
AI/ML that survives post-market
A Predetermined Change Control Plan isn't optional for AI/ML SaMD — it's what keeps your model update pipeline moving after clearance without re-submitting.
Risk files that actually help
ISO 14971 risk management isn't a checkbox. It's the design input that drives your software architecture, your test strategy, and your labeling.
One team, start to finish
The engineers who write your SRS are the same ones who write the 510(k) software section. No interpretation loss between development and regulatory.
Ready to Clear on the First Submission?
Tell us your device class, regulatory pathway, and where you are in development. We'll identify the gaps and map a clear path to submission.