--- case_studies: - 91deff6e-da15-4f6f-9ce3-04d17641bb51 - 141bd5b7-a754-80c4-8e9a-fa24807a2e59 - 30abd5b7-a754-8063-90d4-ea45a37122f6 description: We guarantee AI/ML SaMD FDA submission and clearance in 9 months. featured: true is_solution: true service_name: Guaranteed AI/ML FDA Clearance sort_order: 9 title: Guaranteed AI/ML SaMD 510(k) widget_icon: - /img/services/guaranteed-aiml-fda-clearance-2b151a8054.svg ---
# 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**
## Testimonials
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](https://innolitics.com/articles/):
# 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:

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.