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 Medical Device Software

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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Documentation for 510(k) Submissions

If you've nearly finished the development of your device but need to write the documents for your 510(k) submission, we can help. We can provide templates and self-help resources, consulting, or we can work with your engineers to draft the documents for your submission, all for a fixed-price using a proven process.

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Engineering Staff Augmentation

We can help your team meet an aggressive milestone. We can help with new feature development, refactoring of existing software, software verification and validation, and more.

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Other Services

We also offer several other services, including:
  • Hourly Regulatory Consulting
  • IEC 62304 Gap Analysis and Remediation
  • Writing DICOM Conformance Statements
  • Cybersecurity Penetration Testing

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Why Innolitics?

Unlike less specialized software engineering teams, we move fast. We know IEC 62304 and the growing list of FDA Guidance. We also have regulatory experts on staff.

When you hire us, you hire the shared expertise of a talented 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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