Your device deserves to
reach patients.
We're the engineering partner for MedTech companies who need to move from concept to FDA clearance ; without building an in-house team to do it.
Great devices stall. Not because the idea is wrong ; because the evidence isn't there.
The FDA doesn't approve devices. It approves proof. Most delays come down to the same five problems:
- ▲ Requirements that can't be tested → delayed V&V
- ▲ Traceability gaps → regulatory rejection
- ▲ Sensor data not validated under real conditions
- ▲ Software issues caught during FDA review
- ▲ Designs that can't scale to manufacturing
We fix these before submission. Not during.
One thing most founders miss:
Your product becomes a regulated medical device based on what you claim it does ; not how it's built. A wellness tracker can become a Class II device overnight. Software alone can trigger FDA oversight. Getting this wrong costs months.
Innovobot helps you understand your regulatory classification early ; so it doesn't become a surprise during submission.
One partner. Concept to cleared.
Hardware, firmware, software, sensors, and regulatory documentation ; owned by one team, not assembled from five vendors.
Sensor & signal engineering
Accurate data is non-negotiable in medical devices. We solve the problems that kill sensor reliability in the real world.
- ECG, EMG, EEG, pressure & temperature biosensors
- Signal noise, skin contact variability, placement
- Calibration and accuracy validation
- Low-power wearable systems
Hardware, firmware & software
Full-system design ; not components handed off between teams.
- Electronics and PCB design
- Embedded firmware and control logic
- Safety-critical software (IEC 62304)
- Wireless pipelines, HMI, motion control
Regulatory & compliance
Built in from day one ; not patched on before submission.
- Design controls (21 CFR 820 / ISO 13485)
- Risk analysis and FMEA
- V&V protocols and automated test systems
- 510(k) and PMA submission packages
Production readiness
We design for scale from the start ; not after the prototype passes.
- DFM and manufacturing documentation
- Automated calibration platforms
- Reliability validation under real-world conditions
- Quality systems for commercial deployment
Devices we've shipped.
Real programs. Real outcomes.
Life-sustaining heart pump system
Full device software, 100+ safety conditions, complete verification protocol. The engineering was solid ; the challenge was building evidence the FDA couldn't challenge.
Dry eye treatment device
Complete electronics redesign, firmware, risk analysis, and regulatory package. Six months of rework was baked into the previous development path. We removed it.
Stroke rehabilitation device
Detect minimal voluntary muscle activation. Translate patient intent into assisted movement. Signal-to-noise under real patient conditions ; not a lab setup.
Catheter sensor calibration platform
Automated calibration and test system for a critical cardiac sensor. Full traceability, aggressive timeline, hardware-software integration under strict tolerance requirements.
Structured. No gaps between engineering and compliance.
Requirements & classification
Regulatory path, user needs, testable system requirements ; defined before a line of code or a circuit is drawn.
Design with risk built in
Hardware, software, firmware ; with FMEA and mitigation embedded in design decisions, not appended later.
Verification & validation
Every requirement traceable from origin to evidence. Automated test systems where possible.
Submission-ready package
510(k) or PMA documentation structured for reviewers. We know what triggers a deficiency letter.
Scale to production
DFM, quality documentation, manufacturing validation. Designed in from the start.
- Engineering & compliance siloed
- Requirements not structured for V&V
- Multiple vendors, handoff gaps
- Prototype-first, scale later
- FDA feedback loop discovered late
- One team, full accountability
- Every requirement testable & traced
- Hardware through submission, no gaps
- Production-ready from day one
- First-submission success, every time
Built for companies that can't afford to get it wrong.
We partner with MedTech startups and SMEs that need a full NRE partner ; not a consultant and not a body shop.
Seed to Series B startups
You have a device concept, a small team, and a fundraising timeline that depends on reaching clinical milestones. We become your engineering department.
SMEs entering a new device category
You have manufacturing capability but not FDA submission experience. We bridge the gap from prototype to cleared product.
Teams stuck before submission
V&V gaps, traceability issues, FDA feedback. We've seen it before. We come in, identify exactly what's missing, and fix it.
30 minutes to know where you stand.
We'll map your device program, identify what's blocking you, and tell you exactly what it takes to reach first submission.
"We don't just help you build a device. We help you prove it's safe, effective, and ready ; so patients can actually use it."
No commitment. No pitch. Just a clear picture of your path forward.