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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.
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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

Centralized AI Development Workflow for a Peer-Network Platform

Industry: Fintech
Timeline: January 2026 - March 2026

Tiger 21 Connect is a web platform for a global network of high-net-worth investors. Their engineering team used several AI coding assistants, but each developer configured them differently. None of the tools knew the project's code standards, design files, or ticket structure. Our team built one shared setup that teaches every assistant the same rules, connects them to Figma, Jira, and Confluence, and adds around 40 templates for recurring tasks. Every developer now gets the same quality of AI help, and complex bugs that once took hours to investigate now resolve up to 98% faster.

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    Talay — Mobile App for Watch Collection Management and Loan Creation

    Industry: Fintech
    Timeline: October 2024 - May 2025

    Talay is a fintech mobile app that manages watch collections and generates asset-backed loans. The client required a platform that would allow customers to store and structure their watches, submit standardized data for evaluation, and use selected assets as collateral for loan requests in one interface. Our team designed and constructed the mobile app, created a structured flow for asset onboarding and verification, and implemented a scalable system that connects collections, valuation inputs, and loan origination.

    • React
    • React Native
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    ExpertsNow – Recruitment Workflow Platform

    Industry:
    Timeline: February 2025 - June 2025

    ExpertsNow is a web-based talent and opportunity management platform that helps companies manage candidates, experts, and hiring workflows in one structured environment. The Yojji team designed and developed a full-featured recruitment workflow system. Our client received responsive UI/UX, multi-role dashboards, and scalable architecture to support growing hiring operations.

    • React
    • Node.js
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    Loyal Payment – Mobile Fintech App for Utility Payment

    Industry: Fintech
    Timeline: April 2025 - September 2025

    Loyal Payment is a fintech mobile app for utility bill payments. The client required a simple product that allows users to pay water, gas, electricity, and housing bills in a single interface, track a payment history, and manage various addresses. Our team designed and developed the mobile app, created a scalable structure for multiple services, and simplified payment flows to increase payment transparency and decrease manual steps.

    • React
    • React Native
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    SuperMe – HealthTech Web Platform

    Industry: Healthcare
    Timeline: September 2024 - February 2025

    SuperMe Watch is a company that produces smartwatches for children, encouraging a healthy lifestyle by tracking activity and nutrition. Yojji created a gated online platform that can be accessed after payment using a unique code. It synchronizes the watch with calendars, tasks, food diaries, and progress indicators. Our client received a web platform that connects a physical gadget with a child-friendly website with simple tracking and motivation mechanisms.

    • React
    • Typescript
    • CSS
    • Node.js
    • Gitlab CI/CD
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    Runway5 – Aircraft Marketplace Platform

    Industry: Ecommerce
    Timeline: August 2024 - January 2025

    Runway5 is a web and mobile e-commerce platform for buying and selling aircraft. The request was to deliver UX/UI design and full product engineering with marketplace architecture, subscription-based selling, and contact-to-buy process. Our client received a production-ready marketplace with complex user flows: verified sellers list aircraft, and buyers search, compare, and contact sellers through a structured, compliant flow.

    • React
    • Typescript
    • Tailwind CSS
    • React Native
    • Postgres
    • Gitlab CI/CD
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    Zuzzle – E-learning Platform

    Industry: EdTech
    Timeline: March 2025 - October 2025

    Zuzzle is an online learning tool for organized study of foreign languages and academic disciplines. The product helps students prepare for exams. They have tests, exercises, learning data, and planning tools all in one interface. The Yojji team created this e-learning platform as a scalable system that allows users to schedule daily study activities across desktop and mobile devices, track progress by subject, and examine performance trends.

    • React
    • Node.js
    • Typescript
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    NFT marketplace

    Industry: web3
    Timeline: April - July 2022

    Fortiter is a Web3 NFT marketplace, a membership ecosystem based on NFT ownership. The client needed a platform connected to a wallet where users could view collections, track rarity, and monitor trading activity related to weekly payouts. Our team delivered a functional MVP with wallet integration, a clean interface, stable contract interactions, and real-time market data.

    • React
    • Node.js
    • Google Cloud Platform
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    ExpertsNow — A Modern Hiring Platform

    Industry: Management
    Timeline: September 2024 - May 2025

    ExpertsNow is a European platform where companies can create vacancies, review pre-selected expert profiles, track every hiring stage, and coordinate interviews. The Yojji team defined the product flow, designed the interface, and developed the web and mobile applications. Our client got a working two-sided system that helps companies manage their hiring pipeline and allows experts to respond to new roles in a few clicks.

    • React
    • Nestjs
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    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 Custom LMS for Corporate Learning

      Industry: EdTech
      Timeline: November 2024 - May 2025

      Our team built a custom LMS web application for structured learning with strong community features. The request was to design and develop a platform where users can take multi-format courses, join interest-based groups, chat, track progress, participate in events, and earn certificates. The client received a fully functional and responsive LMS in 6 months.

      • React
      • Nestjs
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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

      Jellibeans is a web and mobile platform that converts large volumes of fashion market data into decision-ready insights for brands and suppliers. We built the MVP to aggregate data from verified sources, visualize complex analytics through an intuitive interface, and help teams track trends, compare competitors, and plan collections without working directly with raw data or spreadsheets.

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

      Industry: MaaS
      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

      StudyHall is a web and mobile learning platform for structured study and exam preparation. It combines AI assistance, grammar practice, and teacher-led assessments to help students work with complex materials more efficiently. Our client got clear tools for educators to track progress and understanding in one system.

      • React
      • Node.js
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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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      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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      AMOD — AI-Powered Interior Design & Furniture Marketplace

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

      A matter of design (AMOD) is a web and mobile platform where users can redesign real apartments, manage subscriptions, save ideas, and buy furniture without switching between separate tools. Our task was to design and develop the full product: secure authentication, subscription and payment logic, AI-based room redesign, bookmarking, and e-commerce functionality.

      • 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 Machine – Time Tracking & Performance Management System

      Industry: Workforce Management
      Timeline: Oct 2018 - Mar 2019

      Our Yojji team built Time Machine as an internal time tracking system because existing tools didn’t match our workflow. The web app allows our employees to log hours by project, add weekly comments, and separate billable from non-billable time. Managers got clear visibility into workload and performance. The main focus was on simplicity, so new team members can start tracking time in just a few clicks.

      • 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 Platform for High-Net-Worth Members

      Industry: Social Media
      Timeline: Jan 2020 - Apr 2020

      Our Yojji experts built a social platform for a private network of 800+ executives, entrepreneurs, and investors who meet regularly to exchange experience and solve business challenges. The platform helps members connect, organize regional events, schedule meetings, and communicate in one secure space. It’s fully synced with Salesforce data. We completed the project in four months, 1.5× faster than the original six-month plan.

      • React
      • React Native
      • Node.js
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      Smart Health – Platform for Healthcare Providers

      Industry: Healthcare
      Timeline: Feb 2020 - Sep 2020

      We developed a web and mobile platform that enables hospitals and medical centers to conduct remote health consultations and structured COVID-19 risk surveys. The system allows organizations to assess individual risk levels, generate personalized prevention recommendations, and create customizable online questionnaires.

      • 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 that enables companies to manage global payroll, oversee payment cycles, and process direct transfers across countries. They approached us to build this system on their financial and legal infrastructure. Yojji led the frontend development and design and contributed to backend tasks. Within two months, users completed their first payroll transactions, and the platform continued to expand with new features.

      • Angular
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      Osu – Open Banking & Payments App

      Industry: Fintech
      Timeline: Mar 2023 – Ongoing

      Osu is a business management and payments app for sole traders, integrated with accounting software. Yojji team built the front end for Osu’s open-banking service. It includes a payment widget and an admin dashboard for tracking transactions, managing users, and configuring features. After the MVP launch, we expanded the product with payment request flows and continue to develop the mobile app with new functionality.

      • React
      • React Native
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      Investment application for parents

      Industry: Fintech
      Timeline: Apr 2020 - Oct 2020

      An Australian financial company partnered with us to build a mobile investment application that allows parents to create separate accounts for their children and invest regularly. The platform supports automated payments, stock price tracking, and portfolio monitoring to accumulate capital over time. Within three weeks, we delivered a fully functional MVP with core investment logic and secure data exchange with backend systems.

      • React Native
      • React
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      Avenue - Workforce Management Solution

      Industry: Workforce Management
      Timeline: Jun 2019 - Nov 2019

      Avenue tasked us with creating a platform for large companies that allows employees to set development goals, schedule lectures, receive notifications, and provide 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

      quote
      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
      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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      quote
      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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