Medical Wearable Products We Develop

We offer the following solutions:

  • ECG, PPG, SpO₂ and temperature monitoring wearables;
  • Rehabilitation wearables utilizing IMU systems, range of motion analysis or surface EMG;
  • Remote monitoring equipment and connected care equipment;
  • Biosensor patches and post-operative monitoring systems;
  • Devices for fall detection and senior-monitoring equipment;
  • Therapeutic stimulation, haptic guidance and drug delivery devices;
  • Smart rings, smart wristbands and condition specific trackers; and
  • Research prototypes ready to develop

Not all the outputs of sensors equal a diagnosis. We distinguish the sensors to provide an appropriate interface for the end-user based on the sensible insights of the sensors.

Relevant Adequate Infosoft Medical Wearable Experience

Our experience in the fields of medical and healthcare wearables embraces the integration of biosensors, the design of embedded software, rehabilitation monitoring, connected apps, and hardware design review.

Used to illustrate the capability of our specialists to solve real-life engineering problems regarding wearables and their software are five different projects involving these devices in practical applications.

Smart Rehabilitation Wearable for Physical Therapy
Rehabilitation

Smart Rehabilitation Wearable for Physical Therapy

We created a device that has features of Nordic nRF52840 processor, motion sensor and optional surface EMG.

The device links movement monitoring with patient app and clinician dashboard.

Our device is designed to provide exercise feedback, analyze range of motion, connect using Bluetooth and integrate with the cloud to enable monitoring during physiotherapy sessions.

Read the case study
Bio-Photonic Wearable Patch for Post-Surgical Wound Monitoring
Bio-Photonic Patch

Bio-Photonic Wearable Patch for Post-Surgical Wound Monitoring

As part of our bio-photonic patch project, we looked into the continuous monitoring of wounds using flexible electronic devices, optical sensors and microfluidic pH measurement.

The engineering focus was on monitoring tissue oxygen levels, integrating sensors and connecting with clinical systems. This case illustrates our knowledge and expertise in working with small devices, difficult sensing conditions and connection with medical data.

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Medical Wearable Design Remediation and IEC 60601 Support
IEC 60601

Medical Wearable Design Remediation and IEC 60601 Support

The BLE-connected therapeutic wearable was assisted by our company in terms of hardware reviews as well as design fixes involving STM32L496VG and Nordic nRF52840 components.

In our advisory role, we considered key aspects of electrical isolation, electromagnetic compatibility, battery safety, wireless coexistence, and production testing.

The project showed our capabilities in advising medical device teams on how to tackle technical challenges before any official testing.

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nRF52840 Stress-Management Wearable Cuff
Stress Management

nRF52840 Stress-Management Wearable Cuff

We created a prototype for a wristband that has PPG sensing, movement measuring, and Bluetooth-connected data logging, along with guided breathing cues through haptics.

Our prototype is based on Nordic semiconductor nRF52840 and makes use of certain rules for processing heart rate and HRV.

The scope of the project covers three prototypes, firmware source codes, schematics, bill of materials, along with the data logging interface.

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Connected Healthcare Wearable Monitoring Application
Connected Health

Connected Healthcare Wearable Monitoring Application

Our developers created a React Native application that utilizes many wearable SDKs and health devices for connected healthcare. The platform allows the user to view all health indicators in one application through connections made via BLE and Wi-Fi.

Our work involved communication with devices, synchronization of data, generation of health summaries, delivering notifications to caregivers, and integration with the cloud for connected healthcare monitoring.

Read the case study

Explore Our Live Medical Wearable App Development Projects

Our expertise in developing medical wearable apps includes BLE communication, fitness and health tracking, cloud and cross-platform mobile app development.

Check out our projects to learn what we have accomplished in the fields of React Native, Flutter and .NET MAUI along with our engineering approaches for integrating wearables with mobile and cloud systems.

Wearfit Pro
React Native

Wearfit Pro : Smart Wearable Ecosystem with React Native

Wearfit Pro integrates smartwatch technology with Bluetooth speakers and translation devices due to its mobile ecosystem made using React Native and Node.js technology stack.

This project involves the tracking of health data, notification synchronization, integration with Apple Health and digital purchase functions. Besides, it serves as proof of our professional experience on the way of creating both wearable companion applications and backend services for connected device interactions.

Google Play App Store Case Study
Health Ring
Smart Ring

Health Ring : Smart Ring Companion App with React Native

The objective of the Health Ring initiative is to create links between advanced smart rings and mobile applications using Bluetooth Low Energy technology.

Utilizing the React Native framework, the application incorporates features for activity monitoring, sleep analysis, heart rate measurement, GPS tracking, and Apple Health synchronization.

The Health Ring project showcases our proficiency in handling data from wearable sensors and displaying health and fitness information using the connected mobile lifestyle.

Google Play App Store Case Study
Benio Fit
Flutter

Benio Fit : Healthcare and Fitness Wearable App with Flutter

Benio Fit utilizes several technologies such as Flutter, Django, and AWS to make it possible to connect wearable devices both for Android and iOS.

The project integrates features such as activity tracking, heart monitoring, insights about sleep, notifications on devices, and synchronizing with the cloud. Our experience relates to the use of BLE technologies and making firmware updates.

Google Play App Store Case Study
AquaFit
.NET MAUI

AquaFit : Connected Aquatic and Land Fitness App with .NET MAUI

AquaFit offers an aquatic fitness program with exercise, land regimen, yoga, nutritional scheduling, and fitness monitoring through one single platform. .NET MAUI has been used to build this application which showcases cross-platform development, shared architecture, as well as offline syncing of data along with personalized fitness feature.

Google Play App Store Case Study

End-to-End Medical Wearable Engineering

Viability, slated use and architecture of the system

We create ideas into verifiable requirements that encompass users, environment, measurement range, alarm alerts, connectivity, operation, arch and failure response. Initial models provide answers to the principle queries such as will the sensing device receive the usable body signal, sustain contact, operate at radio frequencies along with meeting the requirements of power consumption.

The architecture decision is whether to process the data in the cloud or at the location local, use a cellular or a mobile way of transmission and whether to ensure safety while working off-line. The outcome can include requirements, blocks diagrams, inputs on risks, device approach, and the idea of verification.

Integration of a Biosensor along with an analogue-front-end

Various factors affect the readings obtained using a wearable device, including motion, skin color, placement, ambient light, electrode contact, sweat, and electrical noise. This study integrates the technologies of PPG, ECG, SpO₂, temperature, IMU, pressure, respiration, bioimpedance, and sEMG with the use of proper filtering, ADC configuration and shielding methods.

The firmware synchronizes the data, eliminates bad readings, identifies bad contact, and maintains the necessary signal quality indicators. All required algorithms are tested on training datasets and compared against reference methods.

Compact PCB, power and enclosure development

Medical wearables must balance size, temperature rise, RF, electrical safety, battery protection, isolation and comfort. We design rigid or rigid-flex PCBs, power trees, charging, antennas and production interfaces. Current profiling covers sensing, processing, radio, haptics, standby and abnormal scenarios.

Enclosures account for optical windows or electrodes, adhesives, cleaning, ingress protection, charging and assembly. Patient-contacting materials may require biological evaluation; a "biocompatible" material claim does not validate the complete device or contact duration.

Embedded firmware and edge processing

We work to create firmware for RTOS systems or standalone firmware with various features like drivers, gathering data, calibration processes, timestamp and storage functions, BLE GATT or GSM modules, watchdog systems, diagnostics, and the safety of the updates process. Accurate in-edge applications let cut down bandwidth needs and ensure necessary offline activities.

Certain requirements, reviews, traceability, anomaly management processes, and testing can support life cycle and associated processes according to IEC 62304.

Mobile apps, cloud and clinical workflows

We focus on secure onboarding, connection of patient-to-device, background synchronization, quality of data, reminders and alerts escalation. Clinician dashboard will be able to inform about the list of patients, trends, devices health, adherence, thresholds and audits.

Backends may involve AWS or Azure or custom infrastructures along with device identifiers, encryption and policies of access, retention, consent and APIs. If required, we will develop HL7 FHIR interfaces. Product owners must confirm requirements regarding privacy, hosting and clinical workflows.

Regulatory and Quality Readiness

Integrating regulation into engineering processes is our core competency. Reference regulations are dependent on classification, application, market, components used, and the functionality of the software. Regulatory considerations that we take into account include:

  • ISO 14971 regarding risk management lifecycle process;
  • IEC 62304 with respect to software development lifecycle for medical devices;
  • IEC 60601-1 and IEC 60601-1-2 with respect to electrical safety, performance, and EMC;
  • IEC 62366-1 covering usability engineering in terms of safety and use errors;
  • ISO 10993 for planning biological evaluation;
  • ISO 13485 or FDA's QMSR regulations regarding the quality system of the manufacturer;
  • Other standard regulations related to radio communication, batteries, privacy, and cybersecurity requirements.

From February 2, 2026 onwards, the US FDA's QMSR refers to ISO 13485:2016. FDA guidance on designing secure devices and ensuring the availability of documentation from manufacturers has been issued. In the EU, regulation (EU) 2017/745 represents the current rules, while revision of the law is pending. It is important to address up-to-date regulations in practice.

We provide support in terms of traceability, risk controls, design reviews, verification protocols, testing reports, evidence on cybersecurity, SBOM, production tests, and laboratory remediation certifications.

Cybersecurity Across the Product Lifecycle

Connected wearables require security from provisioning through retirement. We use unique identities, authenticated pairing, encryption, secure boot, signed firmware, protected keys and least-privilege access. Threat modeling covers device, app, API, cloud, update service and manufacturing.

Secure OTA should authenticate images, resist rollback where required, tolerate interruptions and report status. Postmarket processes cover vulnerability intake, assessment and remediation. "HIPAA compliant" is not a device feature or general certificate; applicability depends on organizations, data and workflows. We build safeguards while clients establish the full program.

Frequently Asked Questions

What is the difference between a wellness wearable and a medical wearable?

The difference lies in the objectives and claims instead of outward appearance. A product that provides information about diagnosis, monitoring or treatment may be regulated.

Can you develop the hardware, firmware, app and cloud together?

Yes. A unified team can coordinate sensors, connectivity, data models, security, synchronization, dashboards and production tests.

Can you make a wearable FDA or CE compliant?

We engineer against identified requirements and prepare evidence, controls and verification documentation. Approval cannot be promised before intended use, classification, test results and submission pathway are known.

How long does medical wearable development take?

This depends on the level of sophistication of the technology, status of the prototype, validation of the prototype, the device classification, testing and supply chain. A feasibility prototype may take months to develop while the product that is validated or authorized takes considerably longer.

How much does a medical wearable cost to develop?

Cost is driven by sensor complexity, custom electronics, enclosure tooling, applications, cloud scope, cybersecurity, verification, clinical work and certification. A requirements and risk workshop provides a more reliable estimate than a generic per-device figure.

Ashok Patel
Ashok Patel
Senior Engineering Project Manager
AI/ML, DevOps, Data Science & Automation | IoT & C#/.NET | Azure & AWS Expert | Certified AI & Cloud Engineer | 1,500+ LinkedIn Followers
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