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Medical Device Software & Regulatory Services

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) in as little as three months.

Where are you on your Medical-Device Journey?

Our medical-device services span from strategy, to market clearance, and beyond:

Strategy Build and Validate Innolitics’ Medtech OS FDA Clearance Expand
  • Strategy: If you’re just starting out and need general guidance, we can help you determine if your product is a medical device and find a path to market. Our combined software and regulatory expertise lets us find strategies for AI/ML and SaMD devices that most regulatory firms couldn't.
  • Build and Validate: If you're looking for an experienced team of engineers to develop your software, optimize your AI/ML models, handle cybersecurity, and verify and validate your device, we can provide a turn-key engineering solution. We'll develop all of the design documentation along the way so clearance won't have unexpected surprises.
  • FDA Clearance: If you’re nearly at the finish line, with your software list mostly done and you’re in a hurry, and you and need help with your 510(k) submission, we can draft your design documents and submit your 510(k) in 3 months, guaranteed.
  • Expand: If you're looking for engineering resources for an existing medical device, our experienced team can help. Web, native, cybersecurity, AI/ML, interoperability, and more.


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.

Dr. Mark Rosenberg, DO, MBA, FACEP, FAAHPM, FACHT
Retrieve Medical

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
AI Metrics
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We Work With

  • Established device manufacturers looking to rapidly break into the SaMD or AI/ML space
  • Enterprises looking for a turn-key SaMD solution
  • Startups with an engineering team looking for regulatory documentation help
  • Clinicians and researchers looking for a team to help commercialize their research or idea
  • Manufacturers on the market in the E.U., Australia, or other jurisdictions who are looking to submit in the U.S.

Our Services

End-to-End Development

We can help new Software as a Medical Device (SaMD) products get onto the market quickly and efficiently. Our team can work with you to identify the best regulatory pathway to market, design and develop the software, and make the premarket submission. We also provide ongoing maintenance and consulting services once your device is on the market.

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510(k) Documentation

We can complete your 510(k) software documentation in 3 months, guaranteed. If you're working on, or have nearly finished, the development of a medical device but need help with the software and cybersecurity documentation for a 510(k) submission, we can help.

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Why Innolitics?

We Speak Both Languages

Our team of software engineers and regulatory consultants have been helping medical device companies get onto the market since 2012.

Software Engineering Web/Mobile/Desktop Image Processing DICOM/HL7 AWS/Cloud AI/ML Medtech End-to-End Development 510(k) Documentation Regulatory Submissions IEC 62304 Cybersecurity Strategy Process

We're SaMD and AI/ML Experts

All we do is medical-device software, and we provide a unique combination of software engineering and regulatory expertise in one close-knit team. When you hire us, you hire a team united by a shared mission to "accelerate progress in the medical device industry."

Medtech OS

Medtech OS is our platform that we use to get SaMD on the market. It’s purpose-built by engineers who've struggled getting medical devices on the market the hard way for over a decade.

It's more than an eQMS— it’s a fully customizable operating system, built on Notion, that will help your team get to market quickly.

It's the central tool that empowers us to move so quickly.

Our Clients Include

CIRS Company Logo Mobius Medical Company Logo PhotoniCare Company Logo Magnetic Insight Company Logo Corticometrics Company Logo InVivo Analytics Company Logo
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