Partner with ITR

From Concept to FDA-Cleared ECG Medical Device

Leverage our end-to-end services and ISO 13485-compliant processes to accelerate development.

We bring deep expertise in Edge AI, wearable biosensors, and remote monitoring to help you launch innovative ECG products faster.

Explore our ECG Capabilities

Algorithm Accuracy and Reliability

Effective ECG devices rely on advanced signal processing and AI algorithms capable of distinguishing critical arrhythmias from noise. High sensitivity and specificity are essential, as even minor false positives or missed events can undermine clinical confidence and lead to poor patient outcomes.

Developing algorithms that work reliably across diverse patient populations and real-world conditions is a significant hurdle. ITR's strength lies in its ability to develop FDA-compliant AI algorithms, optimized for clinical precision and validated through rigorous testing.

Patient Compliance and Comfort

Data Management and Integration

Regulatory Approval

Cost and Scalability

Battery Life and Power Management

Our SolutionS

Your complete ECG development partner - From algorithms to approval

ITR offers a full suite of services for custom ECG solution development, guiding clients from initial concept through design, engineering, manufacturing support, and regulatory compliance.

Advanced Algorithm Development

We build FDA-grade ECG algorithms that run in real-time on wearable devices detecting arrhythmias, extracting HRV, and providing clinically relevant insights without relying on cloud processing. Optimized for edge AI, our models bring the diagnostic power of cardiology to your fingertip

Hardware & Firmware Engineering

Builds compact, energy-efficient ECG devices with medical-grade ADCs, real-time operating systems, and BLE/LTE connectivity. Firmware enables precise signal acquisition, power management, and secure data transmission.

Software & Cloud Development

Delivers end-to-end platforms for ECG data visualization, remote monitoring, and AI-based health insights. Includes mobile apps, clinician portals, and HIPAA/GDPR-compliant cloud infrastructure with FHIR/HL7 integration.

Regulatory Support

We provide end-to-end regulatory support aligned with ISO 13485, IEC 62304, and ISO 14971, including Design History File (DHF), risk management, and software lifecycle documentation. Our team helps clients streamline FDA 510(k) submissions and seamlessly integrate with existing QMS or deliver turnkey compliance packages.

Industrial & Usability Design

Focuses on user comfort, aesthetics, and medical-grade usability for wearable ECG devices such as rings and patches. ITR follows IEC 62366 standards, leveraging rapid prototyping, user testing, and DFM/DFA optimization to accelerate time-to-market.

Electronics & Mechanical Engineering

Develops low-noise, low-power electronic systems with high-performance analog front-end (AFE) integration and optimized PCB design. Mechanical engineering ensures durability, IP67/IP68 protection, and biocompatibility for long-term wearable use

Seamless End-to-End Services

From product design and engineering (PCB, firmware, application, cloud) to manufacturing support and regulatory compliance, we cover the entire development lifecycle.

Established MedTech Expertise

Over a decade of experience, successfully helping clients develop innovative medical devices, including those achieving FDA 510(k) clearance.

Top-Notch Technical Talents

Access our team with Silicon Valley experience, proficient in the latest MedTech stacks, AI, and industry best practices.

Compliant Design Control

Our integrated development process adheres to rigorous healthcare standards including ISO 13485 (SGS certified), IEC 62304, IEC 60601, and HIPAA.

Proven ECG Platform Capabilities

Demonstrated expertise through our proprietary ECG Monitoring Platform (3-channel patch) and Edge ML Software for real-time analysis, showcasing our ability to build sophisticated ECG solutions.

Two ITR leads and two partners are pictured in a collaborative development setting; one ITR lead engages with a partner in front of a screen displaying ITR and "mjn-neuro" epilepsy system project details.

ITR VN's "Wearable Technologies" booth at MEDICA 2024, a trade fair for medical technology & healthcare in Düsseldorf, Germany, with attendees in the foreground.

Four ITR lead members stand in front of the Impact Technical Resources "Wearable Medical Devices Design & Engineering" exhibition booth.

Six people attend a meeting in an ITR Vietnam office, where a screen displays "WELCOME CDTI INNOVATION". Key participants include two ITR leads, an ITR business development lead, and two partners from CDTI Innovation.

An ITR lead explains wearable medical device design and engineering to a visitor at the Impact Technical Resources exhibition booth, with a display detailing their expertise.

Our Development Process

The efficient path to ECG innovation

Explore the essential stages we follow to design, develop, and deliver cutting-edge ECG technology.

Concept

Product Design & Prototyping

Initial concept development and design exploration
Creating mockups and early-stage prototypes
User feedback integration into design iterations
Developing functional prototypes for testing

Iterate

Risk Management & Iterative Development

Identifying and assessing potential risks early in the process
Implementing risk mitigation strategies
Iterative design and development based on testing and feedback
Continuous improvement of the design to minimize risks

Validate

Verification & Validation

Rigorous testing to ensure the ECG device meets specified requirements (Verification)
Clinical evaluation and testing to confirm the device performs as intended for the user (Validation)
Documentation of testing protocols and results

Comply

Regulatory Submission Support