Medical device software, built end to end.
IVD platforms, Software as a Medical Device, LIS connectivity, and custom solutions, built to the regulatory standards that apply and backed by a real quality system, designed to your use case in an audit-ready manner.
Deep expertise in medical device software, from first requirement to FDA submission. Backed by a fully integrated device shop: instruments, consumables, and manufacturing, under one roof.
One team, the full depth of the stack.
What we do
Device cybersecurity is now a condition of FDA clearance.
Under FDA Section 524B, in force since March 2023, the agency can refuse to even review a premarket submission for a connected "cyber device" on cybersecurity grounds alone. We build threat modeling, SBOMs, penetration testing, and eSTAR-ready premarket documentation into the software lifecycle, aligned to the FDA's 2026 final premarket cybersecurity guidance, so 510(k), De Novo, and PMA submissions hold up on first-pass review instead of being assembled in the last six weeks before filing.
How we build it in, architecture through postmarket
The speed of AI, with the quality of human engineers.
We build AI into our design and development workflow to shorten time to market and lower development cost. Every AI-assisted artifact, and the IEC 62304 and 21 CFR Part 11 records behind it, is reviewed by a seasoned engineer, traced into the design history file (DHF), and verified by our independent V&V team.
A human in the loop, start to finish
Start from something established.
Products
Application Accelerator
A comprehensive instrument software framework with an established verification pathway. Get roughly a six-month head start before you write a line of device-specific code.
LIS Connector
HL7, POCT1-A, and ASTM connectivity between your instrument and the laboratory information system, with interface testing and documentation ready for your submission.
Software your device can depend on.
Whether you're starting from scratch or catching up before a submission, bring us your device details. We'll pair you with a senior medical device software expert to review your lifecycle needs and agree on a clear roadmap.
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