Wearble Medical Device Design & Engineering

Wearble Medical Device Design & Engineering

We specialize in end-to-end development of connected and wearable medical devices, combining expertise in electronics, software, and regulatory compliance to help clients move faster from concept to market.

Our Services

From product ideation to post-market support, ITR provides a full range of MedTech engineering services aligned with ISO 13485 and IEC 62304 standards.

New 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 Life Extension & Generation Upgrade
We maintain and evolve your product post-launch, ensuring it stays reliable, compliant, and competitive as markets and technologies advance.
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.
Regulatory Acceleration Service
We help you navigate global compliance and regulatory submissions, simplifying approvals while ensuring your product meets the highest safety and quality standards.
Offshore Technical Augmentation
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.

Our Expertise

Our multidisciplinary teams integrate hardware, software, and data science to deliver reliable, compliant, and commercially viable MedTech solutions.

Industrial & Usability Design

Designs that balance form, function, and user experience so your product is not only reliable but also intuitive to use.

Electronics & Mechanical Engineering

From PCB design to mechanical housing, we build the core hardware systems that keep your device safe, scalable, and production-ready.

Firmware & Software Development

Embedded systems and applications that run smoothly, integrate securely, and meet the performance demands of medical devices.

Cloud Development & DevOps​

Cloud platforms and infrastructure built for scale enabling secure data handling, AI-driven insights, and efficient deployments.

Edge and Cloud AI R&D

Applied research to bring AI/ML to real-world devices, from edge computing to large-scale cloud processing.

Regulatory Support

Design controls, documentation, and compliance strategies that align with ISO 13485, IEC 62304, FDA, and CE requirements.

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.
Two ITR leads and two partners pose in front of the illuminated "ITR Impact Technical Resources" office logo.

Explore ITR’s MedTech R&D Platforms

Over the years, ITR has built multiple hardware and algorithmic platforms to help partners validate ideas, collect biosignals, and accelerate prototyping.

Each platform is validated, customizable, and supported by our engineering expertise to advance your project from research to development.

Smart ring device with mobile app displaying sleep study instructions and tablet showing a detailed sleep study report.
SENSARING

A medical-grade biosensor ring platform for tracking multi-modal physiological data. Ideal for algorithm validation and device prototyping.

1-Channel ECG
PPG, Skin Temp
IMU
Bluetooth 5.2 + NFC
22mAh Li-Po Battery
SDK Access for Raw Data
Sleeping baby lying on white bedding with a small medical sensor attached to the chest.
TEMPSENSE

A skin temperature sensing module with SDK, enabling thermal tracking for wearable or clinical applications.

±0.09°C Accuracy
Up to 6-Month Battery
Bluetooth 5.2
Real-Time SDK
CSV/JSON Export
Disposable or Reusable
Medical-Grade Adhesive
Person wearing a smartwatch displaying blood pressure and pulse readings with finger about to press the stop button.
WRIST-WORN

A wrist-mounted biosensing platform designed for multi-modal signal acquisition, including PPG, EDA, and motion data. Built for flexible integration and rapid algorithm testing in MedTech R&D projects.

Wrist Optical Sensor
PPG (IR/Green) + IMU
Bluetooth 5.2 + LTE
3-Day Battery
Low-Power Design
Real-Time SDK
Illustration of a wearable medical device attached to the upper chest of a human figure.
ECG Monitoring

A compact, high-fidelity ECG recorder for cardiac monitoring and signal algorithm testing.

3-Channel ECG
Respiration + IMU
Bluetooth 5.2 + LTE
5-Day Battery
Event Marker
Real-Time SDK
Wet Electrode
Black fitness or health tracking device with two white circular sensors and three small copper contacts on a beige to brown gradient background.
HSAT

A full system for sleep tracking & respiratory analysis. Supports modular sensors for HR, SpO2, airflow, and body position.

Fingertip Form
PPG (IR/Green) + Motion
Bluetooth SDK
12h Operation
Research-Grade Signal
Woman holding pills during a virtual consultation with a doctor on a laptop screen.
CARESYNC

A connected care platform integrating multiple biosensors for remote patient monitoring and chronic condition management.

Multi-Device Integration
Real-Time Dashboard
AI-Ready Data
HIPAA/GDPR-compliant  Cloud
Custom API

Trust & Proof

Chosen by startups and global MedTech leaders
Clients & Partners
Citynow Logo
Logo MjnNeuro
Logo MSys
DeviceLab Logo
Sensomedical Logo
VNX Robotics Logo
Individual Systems Logo
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Compliance & Standards
SGS ISO 13485
ISO 27001
IEC 62304
HIPPA COMPLIANT
UKAS MANAGEMENT SYSTEMS 0005
ISO 14971
IEC 60601

Contact & Inquiry

Let’s Discuss Your MedTech Project

Whether you’re exploring early-stage concepts, looking for a reliable engineering partner, or planning your next clinical-ready device - we’d love to hear from you.

Collaborate with ITR to accelerate your innovation
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