510(k) Submitted and Cleared in 9 Months. Guaranteed.

You've built or acquired an AI/ML software medical device (SaMD). Your investors are waiting. Your competitors are closing in.
Every month of delay costs you hundreds of thousands in lost revenue, payroll, and market share
Your team is overloaded, lacks the specialist skillset, or isn't moving fast enough
You need one partner who can guarantee speed and certainty, take it off your hands, and get it done

Our Speed and Certainty Promise

We guarantee your device will be submitted and FDA cleared within 9 months. That's 3 months of intensive engagement with us, plus the FDA review period. This service builds on our Regulatory Strategy engagement, which lays the groundwork for a guaranteed outcome.

"7 weeks to submission and 6 months to FDA clearance. Innolitics delivered exactly what we needed. Fast, thorough, no surprises, and full service." — Dr. Peter Killcommons, MD, CEO Medweb

Why Innolitics?

All we do is software as a medical device (SaMD) and AI as a medical device since 2012
50+ SaMD products cleared through FDA
We have experience with all the flavors of AI enabled medical devices including CADq (quantification), CADe, CADx, CADt, and CADp (predictive)
We have full time MDs, PhDs, software engineers, and regulatory experts on staff
We are the only ones offering a speed and certainty guarantee

Let's Meet!

This is how your competitors are doing it but don’t have time for detours, surprises, and rejections.

We will find the optimal path for you so we can guarantee 510(k) clearance certainty and timeline or a partial refund.

Qualification Criteria

We are the only firm in the industry offering this guarantee. However, not all algorithms qualify. Here are the criteria for our speed and certainty guarantees.

Speed Guarantee

You have gone through our Regulatory Strategy Service
Algorithm must be done and locked
Test data must be collected and you have a source of readers necessary to complete the study designed during the strategy service
FDA submission must be the highest priority for the organization
Algorithm must be containerizable (e.g. Docker) or be deployable as a software library or SDK.

Clearance Guarantee

You have gone through our Regulatory Strategy Service
The algorithm is capable of acceptance criteria and study design outputs from the strategy service
Algorithm must pass the acceptance criteria thresholds as set in the study designed during the strategy service
We are happy to submit with lower acceptance criteria / lighter weight study design but we cannot guarantee clearance certainty

Case Studies

We went from Zero Documentation to 510(k) Cleared in 12 Months

Client’s first medical device. No documentation. 510(k) cleared in 12 months while engineers stayed focused on dev.

Read the Case Study →

510k

We went from idea to FDA clearance in 18 months and first Install for AI Tumor Tracking Software

Prototype → 510(k) → QMS → FDA audit passed. Multi-year partnership with ongoing development.

Read the Case Study →

Software DevelopmentImage ProcessingDICOMWeb-App510k

We Flew Onsite, Read the Code, and Finished the 510(k) Docs in 4 Months

Other consultants couldn’t make progress. We finished their software docs in 4 months — 3x faster than expected.

Read the Case Study →

Guaranteed AI/ML FDA Clearance510kIVD

We Did It All: R&D, Clinical Study, and 510(k) Cleared in 12 Months

Built and cleared an AI cardiomegaly detector end-to-end: algorithm R&D to 510(k) clearance in under 12 months.

Read the Case Study →

Medical Imaging AI DevelopmentSoftware DevelopmentGuaranteed AI/ML FDA ClearanceAI/ML510kImage Processing

We Built a Radiology Workflow Tool and Got It FDA Cleared in 14 Months

Built and cleared a DICOM image processing SaMD in 14 months. Full-cycle: engineering to 510(k) clearance.

Read the Case Study →

Software DevelopmentWeb-AppImage ProcessingDICOM510k

Dental CADe Concept to 510(k). We built the app, trained the AI, ran the MRMC study, cleared the FDA.

We built the app, trained the AI, ran the MRMC study, and cleared FDA.

Read the Case Study →

Guided 510(k)Software DevelopmentWeb-AppAI/MLImage Processing510k

Competitor: 5 years, $500k, no results. Us: 18 months, FDA cleared, IPO filed.

Full-cycle development of GyriCalc, a first-of-its-kind pediatric neuroimaging diagnostic. FDA cleared (K250686) July 2025. Filed for IPO in June 2025.

Read the Case Study →

Software DevelopmentGuided 510(k)Web-App510kImage Processing

We Delivered an AI Regulatory Strategy On Time and On Budget

FDA regulatory strategy and Pre-Submission for an AI platform converting 2D MRI to 3D joint models. Delivered on time and budget

Read the Case Study →

Regulatory Strategy, Q-Sub, and BDD in 4 WeeksAI/ML

Testimonials

7 weeks to submission and 6 months to FDA clearance. Innolitics delivered exactly what we needed. They took ownership of the entire DHF and 510(k) package—documentation, cybersecurity, risk management, the works. When we hit internal roadblocks, they found ways to keep us moving. When scope decisions needed to be made fast, they made the right calls. Fast, thorough, no surprises, and full service. That’s how regulatory consulting should work!

Dr. Peter Killcommons, MD

CEO Medweb

I needed a software development partner to write the software, train the AI, and get FDA clearance. An investor once told me that it would take me $5 million and 5 years to get to where we are now. Innolitics got me here 3 years ahead of schedule and $4 million dollars under budget.

Dr. Andrew Smith, MD PhD

Co-Founder at AI Metrics & Chair of Diagnostic Imaging at St. Jude Children’s Research Hospital

Innolitics’ team epitomized proficiency, professionalism, and precision. Their expertise extends beyond FDA regulations, encompassing intricate facets of DICOM, radiology workflows, and adept software engineering. Venturing into this without their support would have potentially stretched our timeline to 9 months or more. Earning the FDA clearance (K231385), for us, is more than just an accomplishment; it’s a monumental milestone.

Amr Abodraiaa

CEO of Rology

We’re grateful to Innolitics for their expert help in getting our product 510(k) cleared. Our team was totally focused on other objectives, so we were excited to learn about the Innolitics Fast 510(k) service. Working with them was smooth, and now we have an FDA cleared product!

Rob Lewis

CEO of Radical Imaging

Thanks to Innolitics, we were able to complete the software documentation for our 510(k) in just 4 months. They flew onsite to absorb how our software worked and provided detailed guidance. Without Medtech OS, training, and support, I can easily imagine the process taking 12 months. Our engineering team was able to focus on feature development instead of being bogged down with documentation. We tried three different consultants before finding Innolitics. None of them could deliver. Innolitics took the reins and made it happen. I don’t see how we would have completed our 510(k) without them.

VP of Systems R&D

IVD Startup

They were proactive, informative, and very well-versed in the regulatory challenges of AI in medical imaging… Unlike competitors, who sometimes take a blanket approach, Innolitics didn’t throw the baby out with the bathwater. They recognized the good work already done and built upon it… We reviewed other capable firms, but none showed the same depth of understanding of the rapidly evolving landscape of AI and regulatory requirements. Their proactive stance with the FDA gave us confidence that we were in the right hands, compared to competitors who seemed more reactive.

Dr. Jagi Gill, MD

Founder and Managing Director

Working with Innolitics has been a fantastic experience. Their technical and regulatory expertise is exceptional—it’s not just programming; it’s science combined with a deep understanding of FDA regulations. Interacting with their team feels like collaborating with fellow scientists who navigate the complexities of regulatory compliance effortlessly. Their mastery in detailing the ends of the slice ranges (they’ll know what I mean) and guiding us through the FDA process has been impressive. I’ve recommended them multiple times and will continue to do so.

Tim Szczykutowicz, PhD

CEO

During a presubmission meeting, the FDA acknowledged that Innolitics were “extremely advanced” in their understanding of the regulations. The FDA essentially concurred with all of Innolitics’ advice, demonstrating a deep understanding of the regulations, even in the face of ambiguous topics such as CADe vs non-CADe. They expertly, and politely, navigated the FDA call with our best interests in mind while fostering a collaborative exchange with the agency.

Dr. Ilya Pyatnitskiy, MD

Cofounder of AUMI AI

Innolitics are more than a group of top SaMD engineers and reg consultants—they are trusted advisors and are like family. They are a one stop shop for AI/ML algorithm R&D, full stack web development, and FDA regulatory clearance. We built SmileDx, a dental CADe from scratch all without needing to raise external funding and within a reasonable timeframe.

Dr. Richard Ricci, DDS, MS, FAGD

CEO of Cube Click

We have done it before and we can do it for you next.

Our Process: Battle-Tested. Speed and Certainty Guaranteed.

We don’t just hand you templates and wish you luck, we drive the entire process using our proprietary Medtech OS platform—purpose-built for SaMD. We roll up our sleeves and do most of the work for you so your team does not need to learn it for themselves.

Week 1: Strategy and Planning

Intensive strategy workshops to establish your regulatory approach
Immediate delivery: Regulatory Plan locks in your submission timeline
Immediate delivery: Clinical Performance Assessment Plan so you can start validation studies immediately
Define user needs, system requirements, and risk management framework
Establish cybersecurity threat assessment and security risk plan
Document device description and intended use
Our physicians, engineers, and regulatory consultants ensure you have a winning strategy

Sprint 1: Risk, Requirements, and Protocol

Comprehensive safety risk assessment through facilitated workshops
Complete cybersecurity risk assessment and threat model
Document system-level requirements including risk control measures
Create software architecture design with key sequence diagrams
Draft Design Verification Plan and Design Validation Plan
Write Technical Performance Assessment Plan
Prepare Executive Summary and Predicate Comparison
Your engineers focus on containerizing the algorithm—we handle the documentation

Sprint 2: Design and Architecture

Decompose software architecture into detailed hierarchy
Collaborate with your engineers to write Software Design Specification
Complete comprehensive Software Requirements Specification
Draft verification and validation procedures with full traceability
Finalize Substantial Equivalence Discussion and 510(k) Summary
Document device labeling and Package Labeling Justification
Develop Build Checklist for verification-candidate system

Sprint 3: Testing and Submission

Complete User Manual with build and deployment procedures
Write validation protocols for all user needs
Review and approve your verification and validation results
Generate Risk Management Report and Security Risk Management Report
Create machine-readable SBOM and comprehensive cybersecurity documentation
Complete all FDA-required software and cybersecurity documents
Submit to FDA, serve as your regulatory correspondent, and be your advocate all the way to FDA clearance.

Our Publications

We publish what we know. Here are some of our articles and resources:

Definitive Guide to AI/ML SaMD Acceptance Criteria

Setting acceptance criteria incorrectly (too high or too low) can delay your FDA submission by weeks or trigger rejection. This guide analyzed 784 AI/ML medical device clearances to provide concrete, data-driven thresholds. You’ll find specific starting points: AUC of 0.9, Sensitivity/Specificity of 0.8, Dice of 0.8, Kappa of 0.85, and Bland-Altman LOA within ±10% of mean physiological values. Learn which statistical methods FDA accepts most often, how to justify your criteria using special controls and predicates, and what to do when your device fails testing.

Yujan Shrestha

ArticleAI/ML Regulatory

Definitive Guide to AI/ML SaMD Ground Truthing

Here we analyze over 200 FDA 510(k) and De Novo summaries to tease out best practices for AI/ML study designs and adjudication strategies specifically.

Yujan Shrestha

ArticleAI/ML Regulatory

How to Plan MRMC and Standalone Studies for a 3-Month 510(k)

This article shows how to achieve an AI/ML SaMD 510(k) submission in ~3 months by running a compact, well-powered MRMC study while continuously accruing standalone evidence through washout. It clarifies roles, sizing, units, and endpoints, with device examples, flowcharts, and a checklist to prevent rework and delays.

Yujan Shrestha

ArticleAI/ML Regulatory

How to Document AI/ML Algorithms in FDA Presubmissions (Q-Sub)

The article outlines a method for documenting AI/ML algorithms for FDA pre-submissions. It emphasizes clear algorithm descriptions to avoid delays. Key steps include visual runtime descriptions, dataset analysis, non-ML testing, annotation details, AI/ML test plans, and performance metrics. It stresses reducing annotation costs and leveraging existing data while advising comprehensive documentation for effective FDA evaluation.

Yujan Shrestha

ArticleAI/ML Regulatory

AI/ML from Idea to FDA

This article outlines the process of developing an AI/ML algorithm from scratch and getting it FDA cleared. It covers the four phases of the process (Explore, Develop, Validate, and Document) and discusses the costs, time, and data requirements involved. It also provides advice on regulatory strategy, data annotation, and algorithm prototyping. If you’re interested in developing a medical device involving AI/ML.

Yujan Shrestha

ArticleAI/ML Regulatory

How We Develop AI for 510(k)-Cleared Devices

This article outlines Innolitics’ process for developing machine learning algorithms for FDA-cleared medical devices. It covers documentation requirements, common pitfalls (overfitting, data leakage, augmentation errors), and a systematic workflow using four key reports: Input Verification, Data Augmentation QA, Model Performance, and Model Comparison—ensuring safe, effective, and compliant AI development.

ArticleAI/ML

Medical Imaging AI/ML Engineering Guide: Best Practices and Examples

A practical guide for engineers new to medical imaging AI, highlighting common pitfalls—like coordinate-system errors and orientation mix-ups—and providing simple checks to avoid them.Ask ChatGPT

Yujan Shrestha

ArticleAI/ML Software

PCCPs: Best Practices, FAQs, and Examples

With predetermined change control plans (PCCPs), FDA has given manufacturers a great new regulatory tool. In this article, we discuss PCCP best practices and questions based on our experiences with FDA and our thorough research of the FDA databases.

J. David Giese

ArticleAI/ML Regulatory

Medical Device Cybersecurity: Best Practices, FAQs, and Examples

This article provides an in-depth exploration of medical device cybersecurity requirements, including best practices and FAQs. It also includes examples and resources for those looking to implement or improve their own threat modeling processes.

ArticleCybersecurity

Design Inputs: Best Practices, FAQs, and Examples

The FDA says developing your design inputs is “the single most important design control activity,” yet writing good design inputs is difficult. This article presents Innolitics’ answers questions our clients frequently ask us about design inputs and analyzes a number of poorly written example requirements.

J. David Giese

ArticleRegulatory Software

Medical Device SBOMs: Best Practices, FAQs, and Examples

Practical suggestions and tips for authoring SBOMs for medical devices and for using them to monitor for cybersecurity vulnerabilities.

J. David Giese

ArticleCybersecurity

Medical-Device Software Regulations: Best Practices, FAQs, and Examples

A comprehensive FAQ for people who are interested in creating a new medical device software to learn the basics about the US regulations.

J. David Giese

ArticleRegulatory

Unresolved Anomalies: Best Practices, FAQs, and Examples

The “Unresolved Anomalies” document is required for the FDA’s pre-market submissions. This article includes best practices, FAQs, and examples for writing this document.

J. David Giese

ArticleRegulatory

FAQs

How much does it cost?

Pricing depends on your device, timeline, and scope. Contact us for a custom quote.

What are the specific refund terms if FDA rejects or you are not able to deliver on time?

If FDA rejects due to deficiencies in our work (bad documentation, missed requirements, poor submission quality), a partial refund will be given. The refund is not applicable If rejection is due to your device's clinical performance or a clinical study that was less powerful than the one we planned for in week 1.

Do you handle the clinical validation study too?

Yes. Just add data and we can handle the rest. This is done via a separate service.

What if our algorithm isn't quite finished yet?

That's actually common. Week 1 identifies exactly what needs to be finalized. Your engineers typically need to containerize the algorithm and run verification tests during Sprint 3. We provide the protocols and guide the process. If significant algorithm work remains, ask us about bundling our AI/ML Development service.

How much time will our engineers need to commit?

Plan for 1-2 full time engineers for the entire 3 month engagement. We drive the regulatory and documentation work, but your engineers are essential for algorithm-specific tasks like containerization, running verification tests, and answering technical questions.

Do you need access to our source code or model weights?

No. If you containerize your algorithm and can run inference on command, we don't need your code or weights. We work with the inputs, outputs, and documentation. If you want us to help optimize or debug the algorithm, then yes—but that's optional.

What about De Novo submissions?

Yes, we handle De Novo classifications. The process and documentation requirements are more extensive than a 510(k), so expect a longer timeline. We'll scope the full engagement during a discovery call.

What if my device does not contain AI?

We handle that too. Let's chat.

What if we need more than 3 months?

No problem. We also offer slower paced engagements. Let’s chat.

What if I already have a regulatory team?

No problem! We’ll show your team how to move with speed and certainty as long as your team has an open mind to use our templates, embrace our process, and follow our lead.

What if the FDA asks for major changes after submission?

We serve as your regulatory correspondent and handle all FDA communications. If the FDA requests additional information, we coordinate the response. Our clearance guarantee means if rejection is due to deficiencies in our work, you get a partial refund.

Can you work with our existing QMS?

At the end of the engagement, all deliverables will be provided as Word documents that can be stored in any QMS. We must use our templates and software (i.e. Medtech OS) during the project for maximum speed. Medtech OS is built on Notion and provides AI/ML-specific templates, automated traceability, and real-time collaboration. Many clients continue with Medtech OS because it makes subsequent 510(k)s significantly faster.

What if our device doesn't fit your service?

This service works best for:

AI/ML SaMD (software-only medical devices, not SiMD)
Algorithm near completion (or willing to add our development service)
Algorithm is likely to pass validation. We only accept algorithms that are likely to succeed clinical validation testing.
Class II devices with straightforward predicate strategies
Primarily physician/technician-facing devices (patient-facing devices considered case by case)

If your device doesn't fit, we'll tell you upfront in the discovery call and recommend alternatives.

Let’s Go!

In a 30-minute call, we'll assess if your device is a good fit for this service or alternative services and provide a clear path forward.

510(k) Submitted and Cleared in 9 Months. Guaranteed.

Our Speed and Certainty Promise

Why Innolitics?

Qualification Criteria

Speed Guarantee

Clearance Guarantee

Case Studies

Testimonials

Dr. Peter Killcommons, MD

Dr. Andrew Smith, MD PhD

Amr Abodraiaa

Rob Lewis

VP of Systems R&D

Dr. Jagi Gill, MD

Tim Szczykutowicz, PhD

Dr. Ilya Pyatnitskiy, MD

Dr. Richard Ricci, DDS, MS, FAGD

Our Process: Battle-Tested. Speed and Certainty Guaranteed.

Week 1: Strategy and Planning

Sprint 1: Risk, Requirements, and Protocol

Sprint 2: Design and Architecture

Sprint 3: Testing and Submission

Our Publications

FAQs

How much does it cost?

What are the specific refund terms if FDA rejects or you are not able to deliver on time?

Do you handle the clinical validation study too?

What if our algorithm isn't quite finished yet?

How much time will our engineers need to commit?

Do you need access to our source code or model weights?

What about De Novo submissions?

What if my device does not contain AI?

What if we need more than 3 months?

What if I already have a regulatory team?

What if the FDA asks for major changes after submission?

Can you work with our existing QMS?

What if our device doesn't fit your service?

Let’s Go!

Let's Talk