Services

Comprehensive Engineering Solutions to Realize Your Vision

From the first sketch to full-scale production, ITR provides end-to-end engineering that balances speed, compliance, and quality. Our teams ensure every stage is aligned with your business goals, so your product not only reaches the market faster but also thrives once it’s there.

ITR workspace display featuring a silver laptop with a data spreadsheet, an iPad showing data editing options, and a central board with three innovative hardware prototypes surrounded by electronic components, brochures, and business cards. The setting highlights ITR’s expertise in comprehensive technology design and development for digital health, MedTech, and smart automation solutions.

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Our Core Engineering Disciplines

Full-Cycle Product Development

From idea to launch, ITR manages every stage design, prototyping, testing, and validation to accelerate your path to market while ensuring compliance and quality at each step.

Product Lifecycle Management

We maintain and evolve your product post-launch, ensuring it stays reliable, compliant, and competitive as markets and technologies advance.

Regulatory Supports

We help you navigate global compliance and regulatory submissions, simplifying approvals while ensuring your product meets the highest safety and quality standards.

Industrialization & Manufacturing Readiness

We bridge the gap between design and production, optimizing for manufacturability and scalability to reduce costs and minimize delays.

Project Recovery & Technical Rescue

We step in when projects stall or go off track auditing, redesigning, and executing a recovery plan to restore momentum and deliver results.

Dedicated Engineering Teams

Scale your R&D capacity quickly with our skilled engineers. We integrate seamlessly with your workflows, giving you flexibility and speed while you retain full control.

Full-Cycle Product Development

Driving ideas from concept to market

We help founders and product leaders move from concept to clinical-grade reality.
Our approach combines system-level design, hardware/firmware/software co-development, and regulatory integration from day one. Each phase feasibility, prototyping, V&V, and scale-up is structured with traceable deliverables, reducing risks and avoiding rework.

Capabilities include:

Industrial & usability design for regulated devices
Electronics, mechanical, and biosignal acquisition engineering
Firmware & embedded systems aligned with IEC 62304
Cloud-native & mobile applications with HIPAA/GDPR compliance
Verification & validation packages mapped to regulatory submission

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Product Lifecycle Management

Ensuring performance and longevity post-launch

A device’s value is proven post-launch. We provide sustaining engineering and lifecycle support to keep products safe, compliant, and competitive.

We manage:

Post-market surveillance & maintenance updates
Cybersecurity patches, feature upgrades, and obsolescence planning
Performance monitoring & field issue root cause analysis
End-of-life strategy balancing compliance and cost

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Regulatory Supports

Bridging compliance gaps with expertise

Compliance isn’t an afterthought. We integrate regulatory requirements directly into the development flow.
Our team builds and maintains Design History Files, Risk Management Files, and Verification/Validation evidence aligned with ISO 13485, ISO 14971, IEC 62304, MDR, and FDA QSR.

Services include:

Regulatory gap assessments and strategy mapping
FDA 510(k), De Novo, PMA, CE submissions with eSTAR-ready files
Clinical evaluation support and audit preparation
Acting as U.S. Agent for international companies

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Industrialization & Manufacturing Readiness

Optimizing design for efficient production

Scaling from prototype to production requires more than design it demands manufacturability. We work with your CM (or help you select one) to ensure smooth handoff and predictable ramp-up.

Focus areas:

Design for Excellence (DfX: DFM, DFA, DFT, DFSC, DFR)
Pilot runs, IQ/OQ/PQ validation, and test fixture development
Supply chain evaluation & optimization
Early cost modeling and process qualification

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Project Recovery & Technical Rescue

Rescuing projects and restoring momentum

Not every project runs as planned. When milestones slip or costs spiral, we step in.
Our process begins with a technical audit covering design files, firmware code, and regulatory status then delivers a practical recovery plan.

Typical interventions:

Architecture or codebase refactoring
Hardware redesign for reliability or manufacturability
Risk re-mapping & regulatory compliance catch-up
Hands-on project management to re-align delivery

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Dedicated Engineering Teams

Expanding capacity with skilled professionals

We extend your R&D capacity with engineers who work as part of your roadmap, not as detached contractors.
Each team is built around your needs HW, FW, SW, AI/ML, QA and is integrated with your sprints, PM workflows, and compliance processes.

Engagement models:

Embedded engineers augmenting in-house squads
Dedicated offshore pods managed by ITR
Hybrid teams combining local presence and offshore scale
Long-term partnership with knowledge retention and IP security

ADVANCED METHODOLOGIES

Transforming Ideas into Breakthrough Products

At ITR, we guide your product from concept to mass production with rigor and agility. Our process ensures quality, speed, and compliance with the highest industry standards so your innovation can reach the market with confidence.