Medical Device Software Engineering & Regulatory

We Speak Both Languages

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

A venn diagram showing our service offerings

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 on-going 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?

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."


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.

Andrew Smith, M.D. Ph.D.
CEO of AI Metrics

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. The Innolitics team is efficient, fair, and highly ethical. They are an absolute pleasure to work with.

Ryan Shelton, Ph.D.
CEO and Co-founder of PhotoniCare
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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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