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Medical Device Software Development Company

Convert innovative hardware into commercially viable health solutions with Yojji's medical device software development services. Our IEC 62304-compliant engineers build cybersecurity, usability, and regulatory compliance into every line of code, whether it's embedded firmware, RTOS drivers, cloud dashboards, or companion mobile apps. Once you've validated the fabrication feasibility of a Class II wearable prototype or know when to scale from a Class III therapeutic platform, our work is to cut down certification and compliance timeline, minimize the friction of data integration, and architect solutions that allow for extensibility in the deployment of AI and remote monitoring. We're your partner in helping you build an audit-ready software product that can be validated as quickly and thoroughly as possible.

Medical Device Software Development Services We Offer

From concept validation to post-market surveillance, Yojji provides the complete range of expertise for medical device software. Each service maps directly to the IEC 62304 life-cycle stages and is supported by ISO 13485-certified processes, providing you with a single partner for innovation, compliance, and sustained performance.

Strategy & Consulting

We design structured roadmaps before any coding is written by the cross-business specialists—product managers, regulatory experts, and solution architects—who will help you shape clinical objectives, target indications, and go-to-market constraints. You want risk matrices, budget forecasts, and roadmaps to effectively articulate requirements and risks that support the FDA, Medical Device Regulation, and IEC 62366 with your business key performance indicators. Ultimately, we provide a validated product strategy that minimizes the need for rework, reduces time to certification, and improves return on investment.

Custom Software Development

When our engineers develop embedded firmware, real-time algorithms, and companion mobile/web applications, we convert the signals generated from the hardware into useful data. As engineers, we adopt modern software stacks (C/C++, Rust, Kotlin, Flutter) and secure coding guidelines (MISRA, CERT), while optimizing for deterministic performance, low power, low memory, and tight cybersecurity. Continuous integration pipelines with automated unit and integration tests ensure every build is completely reproducible and ready for audit.

System Integration

More commonly, devices do not stand alone. We engineer middleware and APIs with security that connect your device to HIS, Cloud Analytics, and Third-party Wearables, specifically for connectivity options such as Bluetooth LE, Wi-Fi, or cellular gateways. HL7/FHIR mapping, DICOM compatible, and real-time data normalization create fluid clinicians' workflows and traceability that speaks regulatory standards (from sensor to screen), no matter how multi-platform the ecosystem becomes.

Quality Assurance & Compliance

Our QA lab employs static analysis, hardware-in-the-loop simulations, and complete verification processes as defined in the IEC 62304, ISO 14971, and FDA 21 CFR Part 820 documentation. Our auditing includes software-of-unknown-provenance (SOUP), cybersecurity penetration testing, and generation of DHF artifacts to be submitted for notified-body, regulatory review. This process allows for a proactive level of rigor that meaningfully reduces regulatory queries and greatly de-risks your clinical trials.

Ongoing Support & Maintenance

After launch, we place ourselves on-call with 24/7 real-time monitoring, automated OTA update capabilities, and continuous attention to any new CVE, regulatory guidance, or post-marketing complaints. Performance analytics can reveal battery optimization opportunities or simple UX refinements, while serialized post-market surveillance programs can funnel real-world evidence back into your product pipeline. You receive a perpetually compliant, living-device platform that can safely evolve as user and market needs evolve.

Case Studies

  • All Cases
  • Healthcare

Healthcare Booking Platform

Industry: Healthcare
Timeline: December 2024 - July 2025

Our team designed and developed a custom healthcare booking platform where patients can search doctors, view real-time availability, and book appointments in a few clicks. It’s a unified system that connects multiple medical institutions, handles payments, and synchronizes bookings with each clinic’s CRM. In 7 months, our client got a fully functional web application.

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    A Platform for Investors

    Industry: Fintech
    Timeline: October 2024 - October 2025

    Our project is a web application for managing investments across stocks, crypto, and private equity. The request was to design, develop, and launch the platform with a focus on trading logic, data integration, and user experience. Our client received a fully functional, investor-ready platform with customizable dashboards and precise analytics.

    • React
    • Typescript
    • Node.js
    • Postgres
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    Infinightly – Smart Social App

    Industry: AI
    Timeline: October 2024 - August 2025

    Infinightly is a social event management app for modern event creators and attendees. Over 10 months of collaboration, our Yojji’s team transformed the idea into a full-featured social ecosystem where users can effortlessly explore, organize, and manage every stage of their event journey. It also helps reduce event setup time by over 40%.

    • React Native
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    AI-Powered Virtual Fitting Room

    Industry: Ecommerce, AI
    Timeline: August 2025 - October 2025

    The AI-powered Virtual Fitting Room is our solution that lets users mix and match outfits and instantly see how each look fits using an AI model or a personal photo. It helps fashion brands personalize shopping, increase conversions, reduce returns, and provide a confidence-driven user experience without complex integrations.

    • React
    • Tailwind CSS
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    Jellibeans - AI Fashion Analytics Platform

    Industry: AI
    Timeline: March 2022 - October 2024

    Aggregating comprehensive real-time fashion market insights from diverse verified sources, Jellibeans transforms raw data into actionable strategies for brands and suppliers. By integrating advanced analytics with multiple dimensions, the platform ensures precise trend predictions and industry foresight.

    • React
    • Nestjs
    • Google Cloud Platform
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    RideNow – Urban Rental App for Scooters and E-Bikes

    Industry:
    Timeline: January 2025 - October 2025

    The client needed a rental app that allows users to easily book, unlock, and pay for scooters, e-bikes, and e-motos. In just 5 months, our team delivered a fully functional, scalable urban rental app and admin system. It helps optimize logistics, reduce maintenance costs, and scale their services across different cities.

    • React Native
    • Postgres
    • JS
    • Nestjs
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    StudyHall - Online platform for teachers and students

    Industry: EdTech
    Timeline: February 2024 - November 2024

    An innovative EdTech platform that leverages artificial intelligence to provide personalized learning experiences. It offers a wide range of interactive tools designed to help students and professionals enhance their knowledge, improve retention, and achieve their learning goals more effectively.

    • React
    • Node.js
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    CSI Helsinki Leading Legal Software Solutions

    Industry: Legal
    Timeline: August 2021 - September 2023

    CSI – Creative Software Innovations is a software house devoted to developing solutions for the legal industry. The company stands out as a reliable and financially stable partner, offering advanced and continuously evolving software that helps law firms maximize efficiency and business value.

    • React
    • React Native
    • k8s
    • Docker
    • Nestjs
    • Azure DevOps
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    STB Union — on a Mission to Make Finances Convenient for Everyone

    Industry: Fintech
    Timeline: February 2020 - Present

    STB Union, a major FinTech player, partnered with Yojji to evolve from a traditional currency exchange network into a modern financial marketplace. The project aimed to develop a secure, scalable platform for multi-currency wallets, international transfers, and digital card services, using React JS, React Native, and Java to enhance STB Union’s service offerings and strengthen its position in FinTech.

    • React
    • React Native
    • Java
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    A matter of design

    Industry: Ecommerce, AI
    Timeline: June 2023 - November 2023

    Discover AMOD, an AI-powered interior design and furniture shopping platform in Hong Kong, transforming the design experience with user-centric technology. This case study reveals AMOD’s journey - its goals, achievements, and strategies - creating a digital space for design enthusiasts and furniture lovers, reshaping the furniture shopping experience.

    • Nestjs
    • Cloudflare
    • Postgres
    • Redis
    • Github actions
    • Docker
    • Terraform
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    Worldwide Remittance SaaS Platform

    Industry: Fintech
    Timeline: Jan 2017 - Feb 2020

    Vala facilitates direct money transfers between businesses, reducing transaction costs and creating new revenue streams. Our team handled the UI design, revamped the application’s admin panel, and built a mobile version from scratch. Ultimately, we were given full autonomy over project design and development decisions.

    • React
    • React Native
    • Java
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    Time Track System

    Industry: Workforce Management
    Timeline: Oct 2018 - Mar 2019

    The Time Machine app is designed to easily track and manage work hours. It features weekly timesheets for setting time frames and adding comments, all within an intuitive interface. We created this app to meet the client’s requirements, enabling employees to track task time by project and fostering streamlined team communication. Additionally, it provides top managers with tools to assess individual performance effectively.

    • Vue.js
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    Covid-19 Symptom Screening & Tracking for Schools

    Industry: Healthcare
    Timeline: Mar 2022 – Present
(~1 year)

    Symptomatical is a symptom management system developed to help companies and schools reopen safely and proactively manage COVID-19 risks. Our team enhanced the platform with analytics tools, an admin dashboard, a secure authorization system, a dedicated landing page, and Stripe API integration. This solution supports daily health screenings, enforces safety protocols, and ensures seamless operational continuity.

    • React
    • React Native
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    Social Network App

    Industry: Social Media
    Timeline: Jan 2020 - Apr 2020

    Our client is an exclusive network of over 800 high-net-worth individuals, including executives, entrepreneurs, and investors, dedicated to expanding business connections, sharing insights, and solving investment challenges. The company engaged our team to develop an online platform to streamline member interactions, support networking, and simplify meeting scheduling, enhancing community connections and collaboration.

    • React
    • React Native
    • Node.js
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    Smart Health

    Industry: Healthcare
    Timeline: Feb 2020 - Sep 2020

    We developed a robust software solution for hospitals and medical centers to conduct remote health consultations and COVID-19 surveys, with a focus on informing patients about illness prevention. Our client needed a tool to survey patients, especially the elderly, assess their risk, and provide customized recommendations based on responses. Additionally, we enabled healthcare organizations to create and customize their own online surveys, enhancing patient support and safety.

    • React
    • React Native
    • Node.js
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    Cross countries payroll solution for SMB

    Industry: Fintech
    Timeline: Oct 2018 - Aug 2019

    Payroll is a $1.2b cloud-based solution enabling companies of all sizes to manage global payroll, facilitate direct money transfers, and oversee payment cycles. They approached us in January 2019 to build this system on their financial and legal infrastructure. Yojji led the front-end development, including design, and contributed to back-end tasks. Through close collaboration and our team’s expertise, we successfully developed an efficient payroll system from scratch.

    • Angular
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    Payment system for entrepreneurs from scratch

    Industry: Fintech
    Timeline: Mar 2020 – Oct 2022

    Osu supports sole traders with a business management and payment app integrated with accounting software. The client initially asked us to design and develop the front end for their open-banking service, including a payment widget and admin system. Yojji delivered a widget and dashboard for merchants to track payments, manage users, and customize features. After a successful MVP launch, we continued developing an app to create and track payment requests. Today, we’re actively enhancing the mobile app with new features.

    • React
    • React Native
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    Investment application for parents

    Industry: Fintech
    Timeline: Apr 2020 - Oct 2020

    This feature-rich financial mobile app offers investment opportunities for parents looking to secure their children's futures. They approached us to build this innovative fintech platform from scratch. In just three weeks, we successfully delivered a fully functional MVP within a tight timeframe, meeting all client expectations.

    • React Native
    • React
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    Workforce Management Solution

    Industry: Workforce Management
    Timeline: Jun 2019 - Nov 2019

    Avenue tasked us with creating a platform for large companies, allowing employees to set development goals, schedule lectures, receive notifications, and give feedback. Using Scrum with two-week sprints, our PM ensured smooth communication and quick issue resolution. After launching the MVP, we provided biweekly updates, efficiently incorporating client feedback and new features.

    • React
    • React Native
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    Types of Medical Device Software We Develop

    To fully realize the clinical utility of modern healthcare gear, equally complex software is required. Yojji encompasses every software category that regulators recognize, from standalone algorithms that are considered medical devices in and of themselves to intricate cloud architectures that link fleets of sensors.

    SaMD (FDA Class I–III)

    At Yojji, we build and validate standalone software like AI triage tools, dosing calculators, and digital therapeutics that adhere to the FDA's SaMD guidance and IEC 62304. Because risk classification drives the depth of our documentation, we offer lightweight verification of Class I, exhaustive hazard analysis, cybersecurity controls, and clinical evaluation reports of Class III. Continuous integration, locked build environments, and maintaining complete traceability of Design History File (DHF) artifacts ensure that every release is audit-ready, reproducible, and the same from release to release.

    Embedded Software for Connected Devices

    Our firmware developers work in C/C++ and Rust to develop deterministic code for both low-power wearables and implantable stimulators while optimizing for limited memory, battery life, and electromagnetic compatibility. We employ secure bootloaders, over-the-air (OTA) update frameworks, and MISRA coding standards to mitigate field failures, supply chain issues, etc. We are even able to test edge cases—latency spikes, packet loss, etc., via hardware-in-the-loop rigs—while the device is still in the lab.

    IoMT Platforms

    We design cloud and edge platforms that connect and manage thousands of devices, gather real-time vitals, and provide FHIR/HL7 APIs to EHRs and analytic engines. With microservice architectures, container hardening, and zero-trust networking, these platforms also scale and ensure HIPAA-grade security. Clinician dashboards are role-based, can monitor fleets easily, and provide automatic provisioning with automatic certificate rotation to minimize IT workload.

    Diagnostic & Imaging Software

    Our teams have DICOM domain knowledge combined with GPU-accelerated algorithms to develop PACS viewers, 3-D reconstruction readers, and AI-assisted detection systems. We have modality work-lists, dose management, and structured reporting designed to fit within existing radiology workflows. We support the FDA 510(k) process, reader-study design, and image-quality assurance to help you ready your system for clinical use.

    Remote Monitoring Applications

    We connect Bluetooth LE, Zigbee, or cellular sensors to mobile or web apps that stream encrypted vitals—ECG, SpO₂, glucose, etc.—to a compliant cloud backend. There are intelligent alerts, trend analytics, and two-way messaging to facilitate early interventions in patient care and improved reimbursement from RPM programs. Patient-facing user interfaces conform to WCAG accessibility specifications, and clinician-facing user interfaces generate data mapped to FHIR Observation resources for asynchronous ingestion into EHRs.

    Our Medical Device Software Engineering Process

    Discovery & Requirements Gathering

    Discovery & Requirements Gathering

    At Yojji, we never begin a project without asking ourselves and the client what and why, so our expert teams of medical device developers, designers, QAs, and project managers come together to safeguard the highest quality of services. As an experienced medical device software development company, we communicate to understand your vision, whether you have a solid plan or need help consolidating one. Every decision we make is discussed with our client, so this stage requires many iterations to ensure we build a solid roadmap for the future stages.

    Design & Prototyping

    Agile Development

    Testing, Validation & Compliance

    Launch, Monitoring & Support

    Advanced Technologies We Leverage

    Front-end
    Back-end
    Mobile
    AI
    html
    Html
    next
    Next
    vue
    Vue.js
    typescript
    Typescript
    css
    CSS
    react
    React
    angular
    Angular
    Tanstack
    Tailwind CSS
    Shadcn
    Ant Design
    js
    JS

    Testimonials

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    Yojji successfully delivered the project within schedule. They demonstrated excellent project management via weekly sprint demos and promptly made adjustments based on the client's feedback. Their responsiveness and collaborative attitude were key elements of their work.
    Julian Leung
    Product Manager - A Matter Of Design | Property Tech & Artificial Intelligence
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    quote
    Yojji was an instrumental part of the client’s team, working closely with them to achieve the product’s success. The team was very collaborative and timely, and their performance was amazing. Additionally, their resources were experienced, professional, and enjoyable to work with.
    Alon Zion
    Alon Zion
    Former Co-Founder, Vala
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    quote
    Yojii is impressive both in quality of development work as well as their commitment. Strong focus on delivery, highly technical personnel, flexible approach that allows for rapid development. Strong processes that allow for solid controls.
    Rohit Mahajan
    Rohit Mahajan
    Executive, Performlive Inc
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    quote
    We’re very happy with the way that Yojji works, which is why we’ve spent so much money and engaged them for such a long time. We treat them as employees in regard to responsibilities and expectations, and they haven’t disappointed us.
    Noam Nevo
    Noam Nevo
    Co-founder of OSU
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    As a company, we find Yojji to be excellent development partners - we cannot recommend them more highly and will be very happy to continue working with them in the future.
    Gareth Reese
    Gareth Reese
    Marketing Manager
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    quote
    They are really nice people with excellent technical backgrounds.
    Bjorn Beyersdorff
    Bjorn Beyersdorff
    CEO, Founder
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    quote
    We used Agile project management methodology and were in contact with the team and project manager daily.
    Arvind Sedha
    Arvind Sedha
    Software Development Director
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    quote
    They all had a super positive outlook and were dedicated to getting the work completed to a high standard.
    Philip Black
    Philip Black
    CEO
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    quote
    Yojji has delivered an accessible product with thorough consideration for the client's requirements. Users have commented on the platform's user-friendliness and speed. Moreover, the team is easy to communicate with and provides frequent updates. Their development and design skills are impressive.
    Lisa Ross
    Lisa Ross
    VP of Experience & Tech, Avenue
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    Frequently asked questions

    What is the difference between SaMD and embedded software?

    How long does it take to develop medical device software?

    Do you support FDA submissions and documentation?

    How do you handle version control and software updates for medical devices?

    Can you help modernize legacy software for medical devices?

    Fill out our contact form for a free consultation, or book an online meeting directly via the Calendly link.
    We discuss your project even if you have just an raw idea.
    We choose a model and approach that are suitable for your case and budget.

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    Meet up in person

    NL, Amsterdam

    Ildar Kulmuhametov
    Ildar Kulmuhametov
    CEO, Co-Founder

    USA, Austin TX

    Yevhen Piotrovskyi
    Yevhen Piotrovskyi
    CTO, Co-Founder

    Spain, Madrid

    Timofey Lebedev
    Timofey Lebedev
    COO, Co-Founder
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