Build your healthcare
product better, no matter
what stage
We help healthcare startups with product strategy, engineering, and compliance from day one.
2-Minute Readiness CheckKnow your regulatory risk, before you spend a dollar building.
Answer 3 questions to get a readiness snapshot, a potential FDA pathway, and the areas most worth validating next.
Informational • Not Regulatory Advice • 3 Questions
Your healthcare software can fail because of compliance issues, even when you think your product is ready.
Every stage costs more
when we're not with you.
When compliance is treated as a handoff instead of part of development, every gap compounds.
The longer compliance is delayed, the more expensive it becomes—affordable during planning, costly during development, and painful after launch.
Without us
Stage-by-stage handoffs
Design
Gaps baked in before specs are locked
Build
Hidden issues surface, rework kicks in
Submit
Goes out without full FDA readiness
Rejected
Wrong pathway or missing evidence
Revise
Fixing gaps under deadline pressure
Re-submit
Second attempt with patched docs
Ongoing
Cycles repeat with no end in sight
Total cost exposure
$$$$$$$$
Working together with us
Integrated end to end
Design
Pathway confirmed, fit built in from day one
Build
Clean build, no compliance surprises
Submit
Right docs, right pathway, first time
Cleared 🎉
FDA cleared — on time, under budget
Total cost exposure
$$
Wherever you are,we meet you there
From a napkin sketch to a cleared device on the market, pick your stage and see exactly how we plug in.
Device categories we know deeply.
Across eight major categories, OMO Medical brings predicate knowledge, regulatory precedent, and engineering depth that generalist consultants simply don't have.
Cardiovascular & Cardiac
Monitoring, implantables, diagnostic imaging, wearable ECG
Remote Patient Monitoring
Connected devices, telehealth platforms, home-use diagnostics
Digital Therapeutics
DTx platforms, behavioral health software, prescription digital therapeutics
General & Class II Devices
Broad 510(k) experience across general hospital, and consumer medical
Cardiovascular & Cardiac
Monitoring, implantables, diagnostic imaging, wearable ECG
Remote Patient Monitoring
Connected devices, telehealth platforms, home-use diagnostics
Digital Therapeutics
DTx platforms, behavioral health software, prescription digital therapeutics
General & Class II Devices
Broad 510(k) experience across general hospital, and consumer medical
In Vitro Diagnostics
IVD software, companion diagnostics, lab information systems
Neurology & Brain-Computer
Neural interfaces, EEG/EMG software, neuromodulation devices
Orthopedics & Robotics
Surgical robotics, implant guidance systems, rehabilitation tech
AI & Clinical Decision Support
SaMD, AI/ML-based devices, clinical decision support software
In Vitro Diagnostics
IVD software, companion diagnostics, lab information systems
Neurology & Brain-Computer
Neural interfaces, EEG/EMG software, neuromodulation devices
Orthopedics & Robotics
Surgical robotics, implant guidance systems, rehabilitation tech
AI & Clinical Decision Support
SaMD, AI/ML-based devices, clinical decision support software
Our Trusted Partners
Stop Wondering
If You're Ready.
Get expert guidance tailored to your product, or complete a quick assessment to uncover potential gaps and opportunities.
OMO Medical helps healthcare companies build secure, compliant medical technologies. In partnership with Brooke & Associates, we support FDA-aligned product development, cybersecurity, and regulatory readiness.