Our medical-device services span from strategy, to market clearance, and beyond:
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
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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
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.learn more →
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.learn more →
Our team of software engineers and regulatory consultants have been helping medical device companies get onto the market since 2012.
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 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.