Build your healthcare product better, no matter what stage
We help healthcare startups with their product and engineer compliance in from day one.
2-Minute Readiness CheckKnow your regulatory risk, before you spend a dollar building.
Answer 3 questions and get a directional FDA pathway, a readiness score, and the exact gaps slowing your clearance.
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.
Hand off stage by stage and every gap compounds. The more you put it off, the more you'll struggle in the long run.
The longer integration waits, the more it costs, cheap at the idea stage, painful in the build, brutal after launch. Figures illustrative.
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.
Idea & Concept
Pressure-test the concept before you spend a dollar building. We work out whether it is even a device, how it would be regulated, and what is technically real.
Prototype & Validation
Pressure-test the concept before you spend a dollar building. We work out whether it is even a device, how it would be regulated, and what is technically real.
Build & Engineer
Engineer the real product — with compliance built in as we go, not bolted on. This is where our software and product team lives.
Post-Market & Scale
Clearance is not the finish line. We maintain the device, ship new features, and handle the change management and next clearances as you grow.
Precision consulting for regulated innovation.
From first concept to post-market, our focus is building your software and product. We bring in trusted FDA consultants for regulatory strategy, QMS, and submissions.
SaMD Development
We design and develop Software as a Medical Device from the ground up, with IEC 62304 compliance, FDA alignment, and full software lifecycle documentation embedded from day one.
- IEC 62304
- ISO
- FDA SaMD
- Software
- AI/ML Devices
- HIPAA
Product Development
From design controls to DHF documentation, we guide your product development process to meet FDA 21 CFR Part 820.
- Design Controls
- ISO
- Risk Management
- Usability Engineering
- Software
Concept, Design & Validation
Before a line of code, we pressure-test the idea — feasibility, intended use, an early read on how it'll be regulated, and the prototypes and user research that de-risk the build.
- Design Controls
- ISO
- Risk Management
- Usability Engineering
- Software
QMS & ISO 13485
We build quality management systems that scale with your company — from startup SOPs to full certification readiness.
- ISO 13485
- 21 CFR Part 820
- CAPA
- Audit Readiness
- AI/ML Devices
Regulatory, QMS & Submission
We prepare your technical documentation and coordinate QMS development and FDA submissions with experienced regulatory consultants — so it's done by specialists, not guessed at.
- ISO 13485
- 21 CFR Part 820
- CAPA
- Audit Readiness
- AI/ML Devices
Ready to consult our experts?
Book a consultationDevice 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 is a leader in medical device cybersecurity, offering tailored solutions for security and regulatory compliance. In partnership with Brooke & Associates, we help healthcare organizations protect critical technologies and meet FDA requirements.