MedTech & Healthcare IoT Device Development Company

Searching for a reliable healthcare IoT development company that can handle everything from concept to manufacturing? Adequate Infosoft is a global turnkey IoT healthcare device development firm delivering complete end-to-end medical device engineering services for startups, healthcare enterprises, hospitals, and medical brands worldwide.

Healthcare is being revolutionized by utilizing the Internet of Things (IoT) for connected devices, real-time monitoring and data-driven patient care.

Today, the use of IoT solutions enables improvement of clinical outcomes and increase the efficiency and experience of patients by healthcare providers (hospitals) and healthcare technology companies (MedTech startups, medical devices manufacturers, digital health companies, etc.).

Wearable ECG monitors, remote patient monitoring systems and connected medical devices are creating many new opportunities for the healthcare sector when combined with Artificial Intelligence (AI) platforms.

As part of our end-to-end health IoT development services we offer custom PCB design, firmware development, biosignal capture, cloud connectivity, mobile and web applications, artificial intelligence integration, rapid prototyping and manufacturing assistance.

If you need help turning your idea into a reliable, market ready healthcare solution whether you are building an MVP, validating a new concept or preparing for large scale production we can help.

Healthcare IoT and medical wearable device development

Complete Medical Device Development from Concept to Commercialization

The regulated medical technology landscape can be complicated, and delays from fragmentation can create challenges for your growth.

Working with a single partner will streamline your development cycle, enabling a faster timeline by allowing them to handle all aspects of the process, such as biosignal acquisition, embedded firmware creation, PCB design, mobile application development, regulatory compliance, and mass production. Adequate Infosoft is your single partner for the development of your medical device.

Medical IoT Hardware, Firmware & Manufacturing Company

We are a turnkey IoT healthcare device development company providing complete end-to-end medical device engineering services under one roof. Our team manages the entire product lifecycle including:

  • Medical PCB design & multilayer PCB development
  • Embedded firmware development
  • IoT healthcare device development
  • Sensor integration & biosignal acquisition
  • BLE, WiFi, LTE, LoRa & cloud connectivity
  • Prototype development & hardware testing
  • Medical device casing & industrial design
  • Mobile app development for Android & iOS
  • Remote Patient Monitoring (RPM) platform development
  • FDA, CE, FCC & medical certification support
  • PCB assembly (PCBA) & bulk manufacturing
  • Production testing & mass production support

We provide everything under one roof, from first feasibility study to final production unit, reducing vendor dependency, development delays, communication gaps and manufacturing risks.

We are experts in wearables for healthcare, ECG monitors, Patient Monitoring Systems, AI-powered diagnostics, smart medical sensors, telemedicine devices and custom healthcare IoT solutions.

Here you will find information about our technical capabilities, hardware and firmware stacks, certification process, rapid prototyping workflow and scalable medical device manufacturing approach that helps healthcare companies bring products to market faster, with lower risk and better compliance.

What We Do: End-to-End Medical Device Engineering

We are a Medical Grade IoT Device Development Company with experience, not a design only consultancy.

We are a manufacturer of medical devices with strict quality management systems (ISO 13485:2016). Our capabilities in house include:

We are a medical device design and manufacturing company, with end to end ownership of the entire product lifecycle from concept validation and PCB design to firmware development, enclosure design, testing, certification and bulk production.

We have our own manufacturing capabilities and can leverage partner manufacturing when needed.

This includes the following capabilities:

  • We have the capability to manufacture assemblies with 0201 (the smallest common package type) mountain components
  • We can perform in-circuit testing and flying probe testing to verify that the assemblies meet performance/certification standards prior to shipping them to you
  • We use ultrasonic welding to create medical-quality enclosures (IP67/IP68)
  • We have ESD protection factors (methods) for assembling sensitive analog front-end circuits into assemblies

Engaging with us means no painful transition from factory to design house and/or design house to factory. We do it all.

Complete Medical Device Engineering Services

Our Total Engineering Services (End to End) for Medical Devices provide the necessary support for each layer of the stacked architecture:

  • Clinical requirements translated to user needs specification
  • System architecture (hardware/firmware/cloud/application)
  • Design controls (DHF/DMR/DHR per 21 CFR Part 820)
  • Verification & validation (test protocols/trace matrices)
  • Regulatory support (FDA-510(k) submission ready)

Our goal is to provide you with a complete finished medical device rather than only provide you with engineering documentation.

AI Integration for Smart Medical Devices

We integrate AI into the engineering of medical devices to enable smart healthcare solutions such as predictive monitoring, biosignal analysis, anomaly detection, patient behavior tracking and smart diagnostics.

We have experience with AI wearables, edge AI processing, computer vision and cloud-connected healthcare systems for accuracy, scale and real-time medical insights.

Explore Our Delivered Medical IoT Case Studies

Explore some of our recent medical IoT and wearable healthcare projects to get a sense of our practical expertise in the healthcare industry.

We have successfully built a number of MedTech solutions such as smart wearables, biosensors, BLE devices, remote monitoring systems.

NDA restrictions prevent us from sharing all projects publicly, but here are some recent case studies we can share. Our team has also been recognized several times in the medical technology space and has a lot of experience in developing certified healthcare solutions.

Hardware Engineering: Boards, Sensors, and Radios We Use

As an experienced medical hardware product design company, we develop custom medical devices from concept to production.

Our services encompass custom PCB design, hardware architecture, schematic development, PCB layout, fabrication, prototyping, firmware development and manufacturing support along with testing.

When selecting components for your project we take into consideration performance vs power efficiency vs reliability vs compliance with regulatory requirements (FCC/CE/etc…) as well as assist in streamlining the process for attaining certification and getting your product ready for market.

Microcontrollers & SoCs (Medical Grade)

Use CasePreferred Parts
Ultra-low power wearablesNordic nRF52840, nRF5340 (BLE + Arm Cortex-M33)
Complex sensor fusionSTM32U5, STM32L4 series (low power)
Edge AI / ECG analysisAmbiq Apollo4, NXP i.MX RT crossover
Cellular RPM devicesQuectel BG95 (LTE-M / NB-IoT), u-blox SARA-R5

Analog Front Ends (AFEs) for biosignals:

  • ECG / Heart rate: Texas Instruments ADS1292R, ADS1299, Maxim MAX30003
  • PPG (optical heart rate): Analog Devices ADPD144RI, Maxim MAX86141
  • Bio-impedance (hydration/body composition): Texas Instruments AFE4300
  • Temperature: Texas Instruments TMP117 (medical grade, ±0.1C)

Wireless Connectivity

  • Short-range: BLE 5.2 (Nordic), Thread/Matter, & Zigbee
  • Long-range: LTE M, NB IoT, & LoRaWAN (for use in ambulatory monitoring)
  • To support legacy connectivity: Wi-Fi (ESP32 S3), & SubGHz

We can design your custom PCBs from 2-layer to 12-layer rigid flex, which is required for comfortable wearables.

Firmware and Hardware Development for Medical IoT

Our team of firmware and hardware developers for medical IoT is certified in medical device software development (IEC 62304 Class B/C). We do not treat firmware as an afterthought.

Firmware Stacks We Build On

LayerTechnologies
RTOSFreeRTOS, Zephyr RTOS, ThreadX (Azure RTOS)
BLE stackSoftDevice (Nordic), Zephyr BLE, Espressif IDF
Secure bootMCUboot, TF-M (Trusted Firmware-M)
Over-the-air (OTA)MCUboot + SMP, Nordic DFU, custom binary diff
Sensor driversI2C, SPI, UART – with double-buffering for lossless capture

The Features of Our Firmware

  • Perfectly timed ECG Sampling (Jitter <10µs)
  • Low current (Sleep current <10µA) and long battery life (Months)
  • Watchdog timers, brown-out detection and error logging for fault tolerance
  • Protected keys (ATECC608A) for secure boot, mutual authentication

You will receive a test report (Unit, Integration and Hardware in the Loop) with every firmware release

Medical Wearable Device Development

Medical wearables must combine several elements to function properly, including having high-quality sensors, good battery efficiency, wireless communication capabilities, being comfortable for the end user, and being compliant with regulatory standards.

Our company designs and manufactures custom medical wearables, such as ECG monitors, SpO2 and PPG sensors, health tracking wearables, chest straps, smart patches, and connected health care devices.

We develop connected medical wearables for healthcare providers, and our experience ranges from prototyping to production. Our team builds secure, real-time health monitoring and analytics using embedded hardware, firmware, mobile apps, and cloud-based platforms.

We integrate sensor data across multiple devices - including Bluetooth Low Energy (BLE) devices - while applying our expertise in sensor integration, signal processing, motion artifact compensation, and continuous physiological monitoring.

Additionally, we help our customers develop companion apps and remote patient monitoring solutions for the wearables ecosystem. We assist healthcare providers in the development of reliable and scalable medical wearables that align with modern digital health initiatives.

Contract Manufacturing for Custom Health Tracking Hardware

Most startups fail to scale a medical wearable from 10 prototypes to 10,000 units. We work as a trusted custom health tracking hardware contract manufacturer with:

  • Clinical trial quantities for low-volume NPI (50 to 500 new products)
  • Volume production requirement is 50,000 units/month or greater, with a yield of 99% or higher
  • Traceability will be through laser engraved serial numbers and component-level traceability will include batch and date code
  • Automated functional testers (bed of nails), RF calibration and leakage current testing (per IEC 60601) are used for all tests conducted on each unit

We also handle injection molding for silicone wristbands, medical-grade ABS enclosures, and over-molding for waterproof seals.

Compliance and Trust: HIPAA + FDA Ready

Developers of IoT applications that are HIPAA compliant

As HIPAA compliant IoT developers, we build your data pipeline from sensor to cloud by designing an architecture that includes:

  • A secure end-to-end encryption protocol using AES 256 for data at rest and TLS 1.3 for data in flight
  • Access controls with role based access control (RBAC) and an audit log of all users who accessed patient records
  • Debugging support with secure over-the-air (OTA) updates using signed firmware images, and rollback protection.
  • Providing a Business Associate Agreement (BAA) by default.

FDA Medical Device Development Company

We function as an FDA medical device development company with a proven track record for Class I and II devices (510(k)). Our Quality Management System includes:

  • Design controls compliant with 21 CFR 820.30
  • Software Validation compliant with 62304 (Safety Class B & C)
  • Risk Management compliant with ISO 14971:2019
  • Usability Engineering compliant with IEC 62366 1

We maintain your Design History Record (DHR) and Device Master Record (DMR) in real-time, not retroactively.

Cardiac Wearable Specialization: A Company That Makes Wearable ECG Devices

We develop wearable ECG devices, remote patient monitoring and custom connected healthcare solutions with HIPAA-compliant architecture and FDA-ready development practices.

We have specific depth in cardiac wearables. As a wearable ECG device company, we have delivered:

  • 7-Day Patch ECG (7-day patch that's equivalent to a Lead I ECG)
  • Single-Lead Chest Strap (real-time Afib Detection)
  • Handheld 6-Lead Device (on-demand readings)

Development of ECG algorithms (in-house development) results in >99% AFIB Sensitivity and was developed using the PhysioNet database. We have algorithms to detect both lead detection and motion artifacts; we perform HRV analysis also.

Stage & Cost: Prototype and MVP Development

We believe in transparent, milestone-based pricing. Here is what you can expect when budgeting with us.

Prototype Medical Device Development Cost

A functional prototype (proof of concept, not for human use) generally costs:

  • Simple wearable (activity, temperature) $10,000-30,00
  • Medical grade wearables (ECG, SpO2, HR): $10,000-$70,000
  • Includes: 5-10 hand built units, schematics, firmware source, basic mobile viewer

The prototype medical device development cost is a function of the sensor number, wireless certification prescan and mechanical complexity. After a 2 week discovery phase we give you a fixed price quote.

IoT Healthcare Device Development MVP

DFM, regulatory documentation and production tooling. Market-ready MVP (clinical trial or limited release)

What to Expect:

  • MVP IoT healthcare device development $10,000-30,000-70,000
  • Included with: 50-200 pre-production units, DHF ready for 510(k), cloud dashboard, patient app
  • Timeline: 9-14 months (FDA class-dependent)

We cut cost by re using certified wireless modules (e.g. Nordic nRF5340 DK) and proven firmware libraries.

Hire Engineers to Build a Custom Medical Wearable

Building a Custom Medical Wearable is much simpler with the right engineering expertise. You don't need a full-time employee; you need an expert who can jump into your project immediately. Adequate Infosoft can provide you with engineers to build your custom medical wearable in three different models:

All engineers have a minimum of 5 years of experience in MedTech and have experience with HIPAA and GDPR-compliant projects.

Meet Our Certified IoT Hardware Team

We have a worldwide IoT engineers network, all of whom are certified in the areas of embedded systems and hardware engineering. They collectively have decades of experience building connected solutions across multiple industries (healthcare, industrial, consumer).

As active participants in various leading-edge technology communities, they bring substantial technical knowledge and industry-leading expert skill sets to every project.

Padmanaban

Padmanaban

Luis

Luis

Michael

Michael

  • Wireless Technologies Specialist
  • IoT Solutions Engineer
  • Digital Health Innovator
  • AgTech (Agriculture Technology) Expert
  • MedTech (Medical Technology) Specialist
Vishnu

Vishnu

Peter

Peter

Let's Make Your Medical Device Wearable

You've got the clinical insight. We have engineering backbone. Together we can bring to market an FDA & HIPAA-Compliant Medical Wearable and RPM Platform faster, safer, and at a predictable cost.

Adequate Infosoft is just a call away for a confidential discovery call today. We'll provide you with a ballpark prototype medical device development cost within 48 hours.

Your turnkey IoT healthcare device development firm is ready. Let's talk.

Meets industry leaders who believe in us

Dr. Muruga Raj Rajathurai

Dr. Muruga Raj Rajathurai

Renowned leader, ex-President of MMA(CMA-2022-24) & Commonwealth Medical Association

Dr.Pradeep Sharma

Dr.Pradeep Sharma

The Dentist Dental Clinic & Implant Center

Senior Oral & Dental Surgeon Founder Of MEDODENT-Medical & Travel Facilitator

International Patient Coordinator

International Patient Coordinator

Most Trusted Medical Tourism Company, Since 2010

Telecure Asia

Telecure Asia

Telecure Asia is a health IT company providing customized solutions for diverse telemedicine needs

Meet Our IoT Expert Health Tech Team Leader

Our certified IoT and HealthTech experts assist customers all over the world to navigate every step of the process, from product strategy and embedded development, to regulatory compliance, manufacturing, cloud integration and long term technical support.

Sylvain,Spain

Sylvain,Spain

  1. 15+ Years HealthTech Experience
  2. Expert Teleradiology IT Support
  3. Healthcare Technical Support
  4. Medical IoT Specialists
  5. Global HealthTech Experts
Callum

Callum

  1. Medical Device Development
  2. Concept to Commercialization
  3. Global Technical Leadership
  4. Medical IoT Product Expertise
  5. Regulatory and Compliance Support
  6. Embedded and Cloud Integration
Peter, UK

Peter, UK

  1. Visualisation Scientist at Canon Medical Research Ltd
  2. HealthTech Expert
  3. Medical IoT Specialist
  4. Medical Imaging Technology Expert
  5. AWS Developer Certification
  6. Healthcare AI and Visualization Specialist
Pat, Ireland

Pat, Ireland

  1. Research and Development Engineer at Cook Medical
  2. Ireland Based Medical Technology Expert
  3. Medical Device R&D Specialist
  4. Healthcare Product Development Engineer

Partner with Global Healthcare Organizations

World Health Organization

World Health Organization

 Doctors Without Borders

Doctors Without Borders

 Gates Foundation

Gates Foundation

 AIIMS

AIIMS

 Public Health Foundation

Public Health Foundation

 European Public Health Alliance

European Public Health Alliance

Frequently Asked Questions About Healthcare IoT Development Services

What's different between medical and wellness IoT devices?

Medical IoT devices assist in diagnosing, monitoring, treating, or preventing health problems and can only be put on the market after regulatory approval has been granted. On the other hand, wellness IoT devices help promote overall health and fitness but do not have to meet medical definition standards.

How long would it take to create a healthcare IoT device?

Generally a basic (and unregulated) wellness IoT device can be created in about 6 to 9 months. However most regulated devices typically take between 18 to 36 months due to testing and obtaining regulatory approval.

What does HIPAA compliance mean for healthcare IoT devices?

Healthcare IoT devices must comply with HIPAA laws regarding how they handle patient data. In other words, each healthcare IoT device will have the appropriate security measures in place to protect patient information when creating, transmitting, storing, and accessing those records.

What standards are applicable to firmware for healthcare IoT devices?

The primary standards that apply to firmware in healthcare IoT devices are IEC 62304 (software lifecycle), ISO 14971 (risk management), and ISO 13485 (quality management).

Do AI-based medical IoT devices need FDA clearance before going on the market?

Yes, medical software that uses AI or machine learning will require FDA clearance before being released to the public. The FDA will evaluate AI/ML-based medical software for compliance with regulatory and quality standards.

What Our Clients Say About Us

Client satisfaction is our ultimate goal. Here are some kind words of our precious clients they have used to express their satisfaction with our service.

Leadership That Leads Worldwide

With a physical presence in over 15 countries and a global footprint spanning 25+ countries, we are ready to serve you anywhere. Location, language, or culture is never a barrier, because our global team can work with you in your language. Our strong international team ensures seamless collaboration across borders We have a strong tech team, highly recognized in their domains, with extensive technical expertise.

Why Choose Us ?

We endow businesses with flexible engagement models based on their unique needs. Our strength lies in state-of-the-art technology and affordable consulting services. Try us for fast POCs, full-fledged applications, or technology consulting. Always available for your service.