From Concept to Regulatory Submission
End-to-End Wearable MedTech Engineering
Hardware, Firmware, Software, and Regulatory — all under one ISO 13485 QMS. One integrated team. No vendor handoffs. No compliance gaps.
ISO 13485
Certified QMS
15 Years
IN MEDTECH
FDA 510(k)
track record
100+ Projects
DELIVERED
Why ITR
One integrated team. Zero compliance gaps.
Full-stack, single QMS
Hardware to software under one ISO 13485 system — no vendor gaps, no integration risk.
Compliance from day one
DHF and risk management files built from sprint one — no rework cycles at submission.
Cost-effective at US/EU standards
Same regulatory rigor with optimized cost structure, without compromising quality or compliance maturity.
Proven at scale
Track record supporting FDA 510(k)-cleared products deployed across U.S. healthcare.
Typical End-to-End Engagement
1
Weeks 1 – 4
Discovery & Architecture
Requirements, regulatory pathway, system design
2
Months 2 – 9
Hardware & Firmware Development
Electronics, enclosure, firmware, IEC 62304 records
3
Months 4 – 12
Software & Cloud Platform
Mobile app, cloud backend, algorithm integration
4
Months 10 – 18
V&V, Lab Testing & Submission Prep
IEC 60601 testing, DHF, 510(k) package
5
Months 14 – 18
Manufacturing Readiness
DFM, supplier qualification, CMO handoff
Expertise
Wearables and SaMD
ITR covers every technical domain required for wearable devices and SaMD — from chip-level electronics to cloud-connected clinician workflows.
Wearable Medical Device
Regulated wearables demand simultaneous mastery across hardware, firmware, and cloud — with no room for integration gaps.
- Miniaturized PCB design optimized for wireless performance and power management
- Real-time firmware balancing battery life with product usability
- Enclosure design validated for 24/7 wear comfort and compliance
- Cloud backends for secure data streaming and clinician workflows at scale
- Cybersecurity threat modeling and secure-by-design architecture
- DFM analysis, test lab coordination, and production QC design
SaMD (Software as Medical Device)
Most teams discover too late that IEC 62304 requires traceability from requirements through validation — across the entire lifecycle. Bolting compliance on after development creates rework, delays, and submission risk.
- IEC 62304 lifecycle architecture with documented planning
- Traceability matrices linking every requirement to test evidence
- ISO 14971 hazard analysis and FMEA for risk identification and mitigation
- AI and algorithm development for biosignal processing
- V&V protocols proving functional correctness and safety
- Cybersecurity documentation and risk assessment
We build submission-ready design history files for FDA 510(k), PMA, and EU MDR — and manage regulatory cycles to approval.
Engagement Models
How We Work Together
End-to-End Product Development
Full project ownership from concept through FDA submission. ITR provides a dedicated PM and cross-functional team covering electronics, firmware, mobile, cloud, algorithms, and QA/RA. You define the vision — we handle architecture, development, testing, and regulatory documentation.
Best for
Founders and early-stage teams building from scratch
Timeline
12–18 months typical
Extended Engineering Teams
Dedicated multi-disciplinary team embedded in your org for sustained development. 4–12 engineers across hardware, firmware, software, and QA/RA — operating under ISO 13485 from day one. Your roadmap, our execution. One PM, one QMS, no vendor fragmentation.
Best for
Scaling teams without hiring overhead
Duration
6 months to 3+ years
Specialized Engineering
Expert engineers placed by discipline — firmware, hardware, mobile, cloud, or QA/RA — integrated into your existing team. Each specialist brings deep domain expertise and regulatory training. Scale up or down monthly as project needs evolve.
Best for
Teams with specific skill gaps or short-term surge needs
Engagement
Monthly basis
Regulatory Compliance
IEC 62304 software lifecycle documentation, ISO 14971 risk management, and FDA/MDR submission preparation. ITR creates or remediates your design history file, develops V&V protocols, and prepares your regulatory submission strategy — from engineers with 510(k) submission experience.
Best for
Products approaching FDA 510(k) or CE marking submission
Timeline
2–6 months typical
Low Volume Production
From validated design to first units - without full-scale mass manufacturing overhead. ITR manages low-volume runs including DFM refinement, supplier sourcing, assembly, and quality control. Ideal for clinical evaluations and early commercial launches.
Best for
Companies needing 10 – 1,000 units for pilots, clinical studies or early market entry
Timeline
3–6 months typical
Sensa Platforms
Skip 6 months of hardware development.
Sensa is ITR's proprietary wearable development platform. Production-tested hardware, SDK and cloud infrastructure — ready from day one. Validate your clinical concept before committing to custom hardware design.
- Production-ready hardware modules — no PCB design or enclosure tooling required
- Cross-platform SDK — iOS, Android, Windows — set up in days, not months
- SensaHub cloud platform — real-time data collection, visualization, and secure export
- IEC 62304-aligned development records available to support your regulatory submission
- Clear path: Sensa POC → custom product → manufacturing-ready with ITR as your partner
SensaRing
SensaPatch
SensaBand
SensaTip
SensaNeuro
Who We Serve
Built Around Your Stage and Needs
Building from scratch with no internal team?
Stop losing months to hardware development before your first patient data point. Sensa gives you validated wearable modules from day one — validate your algorithm, build your Series A proof, then let ITR take your concept to FDA submission.
Need MedTech depth without the hiring risk?
ITR embeds a multi-disciplinary team — hardware, firmware, software, QA/RA — under your direction. One ISO 13485-certified QMS. One PM. No vendor coordination overhead. Your roadmap, our execution.
Product built. Compliance gaps?
ITR accelerates your regulatory pathway — IEC 62304 lifecycle documentation, ISO 14971 risk management, FDA 510(k) strategy, and submission-ready DHF. From engineers who have supported cleared submissions before.
Ready to accelerate your MedTech program?
Whether you're a founder validating an idea or a CTO scaling your team, let's discuss how ITR can help. No sales pitch — just an honest assessment of fit.