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We help Medtech companies create and clear Software as a Medical Device (SaMD). We can develop your regulatory strategy, build your software (including AI/ML and cybersecurity), draft your design documents, and submit your FDA 510(k).


50+ SaMD Engineering Projects Completed
50+ FDA Clearances Achieved
17 Full time team and growing
12 years SaMD Experience
8 years Longest Client Engagement
100k Epochs Trained
52k Cups of coffee deployed
788k Lines of code reviewed

Trusted By

Our Services

Software Engineering

We can be your engineering team or work alongside your existing team. We can develop and get FDA clearance in just a year—all from scratch.

FDA Submissions

Our solutions range from just our templates and eQMS software all the way to an accelerated on-site visit to get you FDA submitted in as little as two months.

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FDA AI Letter Review FDA Hold Letter keeping you awake? We can help squash FDA's concerns. We give you pragmatic answers to FDA's objections—especially around cybersecurity and study design. Read More Cybersecurity Remediation FDA cybersecurity requirements got you worried? Our engineers will do a gap analysis and can even implement the remediation for you. Read More Strategy

We help you determine what is possible with a $250k, $2.5M, and $25M fundraising round. We can design your study, craft marketing claims, find your predicate, and validate it all with an FDA presub.

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AI Transformation We are experts at using generative AI tools to help our customers get to market faster. We can 10x your team's productivity too so your organization can stay competitive in the age of AI. Read More Fast 510(k) or De Novo You have a nearly finished product but no documentation, and need to submit a 510(k) ASAP. We use our engineering and clinical expertise to write many of the required documents for you. Read More AI/ML Engineering We built an AI/ML SaMD, did a clinical performance assessment, and got it FDA cleared in just a year. Let's do the same for you. Read More On-demand Consulting

Need a second opinion? Simply pick a time and required experts for a consulting session.

(Our + Your) Team = Dream Team

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Software Validation

Overburdensome V&V can cost you months per release. Let us write your testing plan, write your tests, and run V&V for you.

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Independent Design Review Design reviews need to be performed by individuals with an objective lens, ideally by an independent third party reviewer. Such a review ensures compliance  Read More Mock FDA Submission

A failed FDA submission can be a massive setback costing you months to years of time while your company burns cash. We can review your file to save you the trouble.

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SMART on FHIR Apps We have experience building SMART on FHIR applications and deploying them on Epic and Cerner EHR.  Read More LLM Applications We have experience building LLM powered applications—including fine-tuning.  We can provide a regulatory pathway if it is considered a medical device. Read More Device vs non-Device CDS We help you determine if your clinical decision support (CDS) software needs an FDA submission or not. Read More
Need all of the above?

SaMD from Idea to FDA in 12 Months

  • basecamp-of-everest--people-holding-a-map-planning (1)

    Step 1 - Strategy

    You want to bring an SaMD to market but need help getting started. 

    1. Understand Business Goals
    2. Understanding Software and Clinical Workflow
    3. Develop Regulatory Strategy
    4. Develop a Clinical Validation Strategy
    5. Submit a Presub

  • everest-climbers-building-a-log-cabin

    Step 2 - Build

    Our cross functional team of engineers, clinicians, and regulatory experts to builds your device.

    1. We develop AI, algorithms, VR/AR, DTx, CADe/t/x, and full stack web apps.
    2. We are experts in health IT technologies like DICOM, HL7, FHIR, RIS, PACS, LIS, and EMR
    3. Our code is 62304, 14971, 13485, QSR, and FDA cybersecurity compliant
    4. We deploy on web, mobile, desktop, and cloud

  • everest-climber-packing-up-an-opened-box

    Step 3 - Document

    We prepare all the documentation needed for a 510(k) or De Novo submission using our own SaMD specific eQMS and fine-tuned templates.

    1. User needs, requirements, risk assessment
    2. Verification and validation plan
    3. Cybersecurity documentation
    4. Algorithm performance report

  • everest-climber-double-checking-a-knot-for-safety

    Step 4 - Validate

    We run verification and validation activities, including the technical / clinical performance assessment necessary for FDA approval.

    1. We write and execute unit, integration, end to end, manual, white-box, and black-box testing and code inspection activities.
    2. We collect the data, find the radiologists, manage the study, crunch the numbers, and prepare the report
    3. We run standalone performance and multireader multicase (MRMC) studies

  • everest-female-climber-on-the-peak-of-everest-look

    Step 5 - Submit

    We submit to the FDA on your behalf and manage all communications with the agency.

    1. We submit to the FDA using the most recent eSTAR format.
    2. Forgot your small business determination? No problem. You can borrow ours.
    3. We have a company wide FDA email address to ensure fast response times.
    4. We have a database of FDA objections and know how to respond accordingly
    5. We defer a percentage of all invoices until you are FDA approved!

  • everest-climbers-celebrating

    Step 6 - Approval and Beyond

    Congratulations on FDA approval or clearance! Now let us help you deploy and fulfill your sales commitments

    1. We manage your QMS and handle audits
    2. Software development never truly stops. We continue to maintain your code, add more features, and squash bugs
    3. We are experienced with installing in tightly controlled healthcare IT environments
    4. We can help you hire your own team and install a culture of quality in your organization

Your competition is FDA cleared. They are selling. You are not. Let's fix that.

Let's get your software built and/or FDA cleared before the next trade show or investment milestone.

Don't take our word for it

Trusted by the Brightest Medtech Companies

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Ilya Pyatnitskiy, MDCofounder of AUMI AI
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.
Mircea LazeaTechnical Product Manager - Therapeutic Physics at Mirion Medical

I worked with Innolitics to develop an application that analyzes MR images of our geometric distortion phantoms. It was a quite challenging image-processing project. In the end my company and Innolitics team were able to meet the challenge and built a quality web UI and a robust analysis pipeline. Innolitics seems like a company that is run by engineers who care about doing quality work.

Trudy Estridge, PhDSenior Director Regulatory Affairs

I engaged Innolitics to develop a companion app for a COVID testing kit sold directly to users. The app's purpose was to walk people at home through using the test kit. Innolitics was a pleasure to work with. They worked systematically, beginning with a planning phase to collect and clarify our user needs and requirements and ending with thorough V&V and documentation. I’m proud of the app we built together and would certainly work with them again.

Momen MohamedTechnical Lead at Rology

Collaborating with Innolitics was seamless and productive. Medtech OS resonates with the essence of being crafted by engineers for engineers. The depth of their guidance, peppered with detailed examples, was not just helpful; it was indispensable for our journey.

Andrei MigatchevCTO and Co-Founder at Envisionit Deep AI

We really enjoyed working with Innolitics in reviewing our cybersecurity related documentation and compiling a response to the FDA. We were particularly impressed with their knowledge and expertise in the field, and quick turn-around times to our queries. We look forward to working with Innolitics on future projects.

Amr AbodraiaaCEO of Rology

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.

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Nathan Childress, PhD, DABRAssociated VP at Varian Medical Systems

Innolitics's engineers seamlessly integrate with our existing team. They’ve consistently produced high quality work while helping us solve technical problems in the medical imaging space. In particular, they spearheaded development of a large module that extends our existing product suite. This module has since been cleared by the FDA (K153014) and is live at hospitals around the world. Their work on the module involved software development, researching various image processing algorithms, analysis of these algorithms against real-world data, and writing detailed technical documentation of the system that justified its approach to the FDA.

Todd Wilson, MDChief Medical Officer, EndoQuest

I am superbly impressed by the team at Innolitics. They were able to create a complex medical web application on efficiently and with high quality standards. I was not only impressed with their technical know-how, but also by their excellent communication skills.

Dr. Michael P. C. WattsPresident of Impatterns Solutions

I retained Innolitics to create a demonstration app for Android and iOS platforms. They created an elegant design that resulted in a project that was easy to understand and support. I was very impressed by their speed and efficiency, I will definitely be hiring them again.

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Alex Klose, PhDCTO and Co-Founder at InVivo Analytics

Innolitics has been invaluable in developing some components of our cloud-based analysis software for preclinical imaging. They expertly implemented an AI tool for the analysis of DICOM data and helped us with training and optimizing a prototype neural network. Their developers work independently, handling complex challenges with ease, and deliver top-quality results. It's been a pleasure working with the dedicated and professional team at Innolitics, and we highly recommend their services.

Jonas Fontenot, PhDPresident and CEO of Mary Bird Perkins Cancer Center

We commissioned Innolitics to build a dashboard that integrated with our radiation-oncology EMR. Their team’s clinical experience greatly simplified communication and their perceptive questions and suggestions helped us arrive at a better set of requirements for the project. The final result was clean, easy for our doctors to use, and has already improved the efficiency of our workflow.

Rob LewisCEO of Radical Imaging

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!

Nate Bays, PhDExecutive Director, Tissue Engineering at Valo Health

We partnered with Innolitics to improve and update our team’s analysis software. They have diligently worked to add new features and address the troubled areas of the code to both improve its efficiency, as well as its usability. They work independently solving problems and handling difficult coding situations to deliver quality changes and improvements. These improvements have streamlined our code into a more powerful and concise use interface.

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Ryan Shelton, PhDCEO and Co-Founder of PhotoniCare

Innolitics is an incredible partner and consistently surpasses our expectations. They have an extremely agile team, adapting to our needs across back-end and front-end tasks seamlessly. When we needed support around ISO 62304 compliance for FDA requirements, they jumped right in and provided us compliant documentation. They also assisted us as we developed a regulatory strategy around FDA Cybersecurity and HIPAA Compliance (K191804). The Innolitics team is efficient, fair, and highly ethical. They are an absolute pleasure to work with.

Nick SchmanskyCo-Founder and CEO of CorticoMetrics

The work conducted by Innolitics to complete a complex software port of a core module of our clinical product was outstanding. The clinical product must by cleared by the FDA, and as such, we needed the highest quality workmanship, and close collaboration with a dispersed team. Innolitics performed exceedingly well in gathering requirements, researching, developing and implementing a design, and providing test modules and documentation. Their team's understanding of medical imaging analysis software, and FDA quality processes, was key to the success of the project.

Dr. Heling Zhou, PhDDirector of Data Engineering at Enlitic

I have really enjoyed working with the Innolitics team. We had originally enquired about the Innolitics DICOM conformance statement consulting but expanded them to augment the data engineering team. They helped build out a complex ETL pipeline for AI/ML and helped build out accompanying SOPs for regulatory compliance. They treat our product as if it was their own and integrated seamlessly with our in-house engineering team. Their breadth of knowledge in technical and regulatory matters has helped our team meet deadlines.

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Dr. Andrew Smith, MD PhDCo-Founder at AI Metrics

I needed a software development partner to write the software, train the AI, and get FDA clearance (K202229). 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. Mark Rosenberg, DO, MBA, FACEP, FAAHPM, FACHTCo-Founder and Chairman of Retrieve Medical

We needed a team that would get it done right the first time and independently. As a physician, I was delighted to work with another physician engineer on the team that was able to implement complex clinical workflows with very little input from me or my team. Innolitics delivered ahead of schedule and exceeded expectations.

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Tushar PandeyCEO at SimBioSys

We recently got FDA cleared and Innolitics' responses were absolutely clutch to craft the strategy that finally worked. Unlike other consultants, who wanted us to do more work and spend more money on clinical testing, Innolitics found a path of least resistance using a combination of our existing validation and thoughtful responses to FDA. We received the best Christmas present ever – our 510(k) clearance letter.

VP of Systems R&DIVD Startup

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.

Would you like to be the next success story?

Let's work together to get your life saving device on the market.

Why US?

DIY / In-House
Average Engineering Firm
Average Regulatory Firm
Start Now
Months to recruit
Medical Device Experience
Web / Mobile
Time to FDA Submission
24 to 36 months
24 months to never
6 months
Time to FDA Clearance
8 to 24 months
8 to 24 months
6 months
Yearly Burn Rate
~$500k for engineer, PM, and regulatory specialist
Funds to FDA Cleared MVP
Staff Augmentation
Delay to FDA Submission
12 months
12 months
As little as 3 months
Full Time Employee (FTE) Effort
24 months
12 months
As little as 2 months
Engineer Burnout
Consulting Cost
$15k to $30k
$5k to $500k
Internal Costs
As little as $38k
Opportunity Cost
SaMD Specific Templates
Type of Advice

Let's get you over the techno-regulatory hurdle.

For research use only. FDA Pending.  FDA Cleared. ✅

Meet the Team

17 Full Time Employees who Love SAMD
14 Engineers who Love SAMD
3 Regulatory Experts who Love SAMD
5 AI/ML Engineers who Love SAMD
J. David Giese CEO & CO-FOUNDER12+ years in SaMD Engineering and Regulatory
Yujan Shrestha, MD CTO and Cofounder12+ years in SaMD Engineering and Regulatory
Jim Headshot-1
Jim Luker, RN VP of Regulatory Affairs25+ years in Regulatory
Andrew Smith Headshot
Andrew Smith, MD PhD Clinical Consultant20+ years in Radiology and AI
Steven Headshot
Steven Rothenberg, MD Clinical Consultant10+ years in Radiology and AI
Seth headshot
Seth Lirette, PhD Biostatistics Consultant10+ years in Statistics and Clinical Trials
Reece Headshot
Reece Stevens Senior Software EngineerFull Stack Web, HL7, Rust, FDA, DICOM, Python, AI/ML
Ethan Headshot
Ethan Ulrich, PhD Software EngineerAI/ML, Medical Imaging, FDA, Clinical Studies, Biostats
JP Headshot
Juan Pablo Centeno Software EngineerAI/ML, Medical Imaging, Python, Deep Neural Networks, MONAI
Pablo Headshot
Pablo Hernandez-Cerdan, PhD Software EngineerAI/ML, C++, Python, Image and Signal Analysis, Deep Neural Networks, MONAI
Matt Hancock Headshot
Matt Hancock, PhD Software EngineerAI/ML, Medical Imaging, Python, Deep Neural Networks, MONAI
Grace Adams Headshot
Grace Adams Software EngineerAI/ML, UI Development, i18N, L8N, Full stack Web 
Meri Martinez Headshot
Meri Martinez Project Manager and Regulatory SpecialistFDA, Regulatory affairs, 510(k), De Novo
Ilya Headshot
Ilya Spivakov Software EngineerFull Stack Web, Python, SQL, Linux
Josh headshot
Joshua Tzucker Senior Software EngineerFull Stack Web, Typescript, JS, Python, Django, React
Bimba Headshot
Bimba Shrestha Software EngineerFull Stack Web, C/C++, DICOM, AI/ML
Prahlaad Headshot
Prahlaad Ram Solutions ArchitectProject Management, FDA, 510(k)
Saman headshot
Sam’an Herman-Griffiths Junior Software EngineerFull Stack Web
Mihajlo Headshot
Mihajlo Grčić Ops Manager
Miljana headshot
quinten headshot
Quinten Sodia Software EngineerFull Stack Web, C/C++, DICOM
Russell headshot
Russell Kan Software EngineerFull Stack Web, DICOM, AI/ML


We love sharing our knowledge. You may find these thought leadership pieces interesting.

You have questions. We have answers.


How long does a FDA submission take? Budget 6 months from after you submit until approval
What is the difference between clearance and approval?

510(k)s get cleared. PMAs get approved. De Novos are granted. You need one of any of these to legally sell in the US.

I already built my software. Do I need to rewrite it to submit to FDA. No. FDA is more lenient on the first submission but subsequent software development should follow a controlled process.
Do I need penetration testing? Most likely. The FDA has been firm on requiring penetration tests for all but the most offline software applications.
Do I need to submit my code to FDA? No
Do I need to match my competitor's performance? It is a good idea but not strictly necessary. FDA will block your application if the results are egregiously bad, but you do not need to match or surpass your predicate.
How long does it take to prepare a 510(k)?

If it is your first time and you are doing it without assistance, budget 12 to 24 months depending on complexity and team experience.

Our services vary from intensity, but typically we submit within 2 to 6 months depending on the level of service.

What happens if FDA rejects my application?

FDA typically writes you a letter with their findings and gives you an opportunity and 180 days to address any deficiencies and respond. Failing that, you can always resubmit but you will have to pay the MDUFA fee again.

I got an FDA warning letter. Can you help?

Yes, we can also expedite our services for an additional fee.

I got an FDA Hold (AINN) letter. Can you help?

Yes, we see many whole letters and have strategies to overcome objections with as little work from your side as possible.

Do you do a De Novo application?


I don't like my current consultant. Can you take over?

I'm sorry to hear that. Yes, we get this all the time and we can pick up where the previous person left off.

Do you have experience with AI/ML?

Yes, both from a regulatory and engineering perspective.

Is my LLM a medical device?

It depends. We can share our experiences in a recent FDA presubmission. Please reach out for more information.

Are software only products considered medical devices?

Yes. It does not need to have a hardware component to be considered a "device"

Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

(A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).




What if your services are too expensive?

Our cheapest offering is our templates and example 510(k), which will help you considerably. We have a special discount if you are ok with including links to our website in your publicly accessible device summary.

How much of my team's time is needed for the regulatory submission?

If it is your first time and you are doing it without assistance, expect 12 to 36 full time employee months of effort.

With our services, expect 2 to 12 full time employee months of effort.

What makes you special?

Unlike other regulatory firms, we have software engineers on staff who can provide deeper, more actionable advice for your device instead of just generic guidance that is hard to follow.

Let's Chat