AI Software Development & Custom AI Solutions for Businesses

Custom Medical Device Software Development Services

We offer medical device software development services designed to meet regulatory standards while delivering advanced functionality. Whether you're building diagnostic tools, wearable monitors, or imaging solutions, we create secure, scalable software that powers healthcare innovation.

Trusted Software Development Company By
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Accredited Healthcare Software Developers By

Our Medical Device Software Development Services

  • Custom Software for Medical Devices

    We create software tailored to your device’s function diagnostics, monitoring, imaging, or therapy, ensuring smooth performance and accurate data handling.

  • AI & ML Integration

    Add AI for smart diagnostics, anomaly detection, and predictive insights that enhance decision-making and improve patient care.

  • Connectivity & IoMT Integration

    Enable real-time data sync with IoMT devices, Bluetooth tech, and standards like HL7 and FHIR for seamless healthcare connectivity.

  • Cross-Platform Cloud Solutions

    We build secure, cloud-native apps accessible across mobile, web, and desktop for clinicians and patients anytime, anywhere.

  • Legacy System Modernization

    Upgrade outdated software with modern UI, scalable architecture, and integrated AI while ensuring regulatory compliance.

  • Regulatory Compliance & Security

    We follow FDA, HIPAA, and IEC 62304 standards, using encryption, audit trails, and secure access controls for full compliance.
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We're AI-Powered Medical Device Software Development Company

Modern healthcare demands connected and intelligent devices that deliver real-time insights. At Citrusbug Technolabs, we blend domain expertise with cutting-edge technology to develop medical device software that is secure, adaptive, and future-ready.

Our solutions go beyond basic functionality by integrating AI, real-time monitoring, and decision support tools. From image recognition in radiology devices to continuous vitals tracking in wearables, we build software that improves medical device workflows and patient outcomes.

We also enable data visualization dashboards, custom analytics modules, and integration with EMR/EHR systems to streamline operations and support healthcare delivery.

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Arrange a Call with Expert Medical Device App Developer

Are you searching for best medical device software development companies in India & USA?

Connect with our experienced medical device app developers for expert guidance and tailored solutions that perfectly align with your business goals.

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Developing Different Models of Medical Device Software

01

Remote Patient Monitoring

Enable continuous health tracking with real-time alerts. Aggregate vitals and health data from wearables or in-home devices for better chronic care and post-surgery monitoring.

02

Diagnostic Imaging Tools

Develop software that supports DICOM, PACS, and AI-based scan analysis. Help radiologists and specialists detect anomalies faster and with greater precision.

03

Smart Therapy Devices

Power devices that assist in treatments like insulin pumps, neuromodulation, or respiratory therapy. Automate control settings based on patient vitals and clinical rules.

04

Data Analytics & Reporting

Enable clinicians to view longitudinal data, generate detailed reports, and receive predictive alerts. Custom dashboards help improve care decisions and regulatory readiness.

05

Device Management Systems

Allow manufacturers and providers to manage device updates, firmware patches, performance logs, and user permissions remotely through secure cloud platforms.

06

Clinical & Regulatory Integration

Connect software with hospital systems (EHRs/EMRs), labs, and regulatory data workflows. Ensure easy documentation, version control, and compliance audit readiness.

Avail 15-day Risk-free Trial of Working with Our Top Medical Device Software Developers

We are confident with our Medical Device Software Development Services but we also understand that it takes a while for any medical business to identify the best app development partner for them.

That's why we offer 15 day risk-free trial of medical device app development services. You can avail it by filling the form below.



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    Compliance & Certifications of Medical Device Software We Develop

    We design and develop software that meets global healthcare regulatory and safety standards. Our approach ensures compliance, reduces risk, and accelerates market readiness.

    Start 15-Days Risk-Free Trial

    FDA 21 CFR Part 820 / 11

    Compliance with U.S. regulatory standards for quality systems and electronic records used in medical devices.

    HIPAA

    Ensures data protection for software that processes or stores patient information, especially in monitoring and diagnostic applications.

    IEC 62304

    Software development lifecycle compliance for medical devices to meet international safety and risk management standards

    ISO 13485 & ISO 27001

    Supports secure and quality-assured software development processes tailored for healthcare and medical device companies.

    Secure APIs & Data Encryption

    All integrations and data transfers use end-to-end encryption and OAuth 2.0 protocols to protect PHI and ensure access control.

    Our Medical Device Software Development Process

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    Discover

    We begin by immersing ourselves in your vision, your device’s purpose, and your regulatory landscape. Through detailed research & stakeholder discussions, we map out a precise, strategic plan tailored for medical device software.

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    Design

    Designing software for medical devices is more than aesthetics—it's about usability, safety, and empathy. Our team crafts interfaces that feel intuitive to clinicians and patients alike, balancing innovation with the strict usability standards required in healthcare environments.

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    Build

    When it’s time to build, we combine domain expertise with modern engineering. Using secure, FDA/ISO-compliant technologies and agile development, we create scalable and high-performing software—whether it's for diagnostics, monitoring, or connected care.

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    Deliver

    We don’t just ship software—we deliver peace of mind. By iterating through rigorous testing cycles, refining based on real-world feedback, and aligning with regulatory milestones, we ensure your medical software is safe, reliable, and ready to make a real difference in patients' lives.

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    Why Citrusbug is Your Ideal Medical Software Development Agency

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    Transparency & Integrity

    We uphold the highest standards of transparency and integrity, protecting your medical device software ideas through strict NDAs and secure development practices.

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    On-Time Delivery

    Our team follows a structured, milestone-driven approach to ensure your medical device software is delivered on schedule, without compromising on quality or compliance.

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    Cost-Efficient

    We provide high-quality medical device software development services at competitive rates, balancing cost-efficiency with innovation, security, and long-term scalability.

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    Vast Technical Knowledge

    Our developers bring deep domain expertise in healthcare and AI development, enabling us to build advanced, compliant, and future-ready digital health solutions.

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    QA and Testing

    Each medical device software undergoes rigorous testing to ensure a secure, bug-free, and fully functional product that’s ready for clinical and patient use.

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    24x7 Availability

    Our support team remains accessible around the clock to address queries, updates, or concerns via chat, email, or call, ensuring smooth collaboration at every stage.

    Our Clients

    Project

    Citrisbug Technolabs developed a native mobile app, working with an existing backend structure to implement the API and construct the frontend. They continue to maintain this app for their client.

    client Image
    Rui W (Rae) icon

    Co-Founder

    Review

    I appreciate them being committed to responding to our problems whenever we call upon them.

    • icon
    • icon
    Project

    Citrisbug Technolabs developed a native mobile app, working with an existing backend structure to implement the API and construct the frontend. They continue to maintain this app for their client.

    client Image
    Rui W (Rae) icon

    Co-Founder

    Review

    I appreciate them being committed to responding to our problems whenever we call upon them.

    • icon
    • icon
    Project

    Citrisbug Technolabs developed a native mobile app, working with an existing backend structure to implement the API and construct the frontend. They continue to maintain this app for their client.

    client Image
    Rui W (Rae) icon

    Co-Founder

    Review

    I appreciate them being committed to responding to our problems whenever we call upon them.

    • icon
    • icon
    Project

    Citrisbug Technolabs developed a native mobile app, working with an existing backend structure to implement the API and construct the frontend. They continue to maintain this app for their client.

    client Image
    Rui W (Rae) icon

    Co-Founder

    Review

    I appreciate them being committed to responding to our problems whenever we call upon them.

    • icon
    • icon

    Some Top-Notch Healthcare Software Projects We Developed

    Mediyoga

    We have developed a state-of-art wellness platform for Mediyoga. This platform is aligned with our vision to use technology for human benefits. This platform includes a range of yoga programs customized for different users. This platform allows them to learn new practices while encouraging users to follow them. Through this platform, users can see the set of exercises and learn from them. Additionally, the platform offers a set of cherry-picked yoga programs for different wellness purposes. This platform also allows an offline mode for users to save the content without depending on the internet availability.

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    Mediyoga
    Brainkey

    Platform leverages AI to analyze brain imaging data, providing insights into brain health. Designed for healthcare providers and researchers, the platform enhances early detection of neurological conditions, enables predictive analytics, and optimizes treatment planning. The platform empowers clinicians with accurate and data-driven decision-making capabilities.

    Learn more icon
    Brainkey
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    Mediyoga Mediyoga
    Brainkey Brainkey
    VIEW ALL

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    FAQs on Medical Device Software Development

    We develop software for Class I, II, and III medical devices, including diagnostics, monitoring systems, and wearables. Our solutions are tailored to suit both embedded systems and standalone applications.

    The timeline varies based on complexity, class of device, and regulatory requirements. Typically, development takes 4 to 12 months, including design, testing, validation, and documentation stages.

    Absolutely. We specialize in building interoperable software that integrates with EHRs, HIS, and other hospital systems. This ensures seamless data exchange, improved workflow efficiency, and better patient outcomes.

    We follow a robust SDLC tailored for medical devices, starting with regulatory scoping, risk and usability engineering, secure DevOps pipelines, iterative prototyping, strict validation/verification, and full documentation to meet IEC/FDA/ISO standards.

    We provide comprehensive documentation to support regulatory submissions including Design History Files (DHF), Software Requirements Specifications (SRS), and Risk Management Reports. Our experts can also assist with FDA 510(k) and CE Mark processes.

    Still have a question?