Medical Device Software
Development Services
We help medtech companies overcome regulatory and technical challenges by delivering custom software for medical devices with our expertise in compliance, usability, and system interoperability.
Why Choose Us for Medical Device Software Development
16+ years of experience and 130+ successfully delivered projects
ISO 27001:2013, ISO 9001:2015, and ISO 14001:2015 certified
GDPR compliant and aligned with international data protection standards
4.8/5 customer satisfaction rating
92.7% Net Promoter Score β reflecting strong client loyalty
3.5 years average duration of client partnerships
$1B+ raised by our clients through scalable and secure digital products
Trusted by Fortune 500 companies and Y Combinator-backed startups
Global client presence across the US, Europe, Switzerland, the UK, and MENA
Deep domain expertise as a medical device software development company
End-to-end support for compliant software development for medical devices
Whom We Serve
Medical Device Software We Develop
Medical software must be precise and regulatory-compliantβyet many struggle to meet all three. We provide medical device software development services that ensure safety, compliance, and reliability.
We help healthcare companies build standalone digital solutions that perform medical functions without being part of a hardware device. Our team ensures SaMD products are compliant, scalable, and user-friendly.
Capabilities:
- Diagnostic and monitoring tools
- AI-powered image and signal analysis
- Digital therapeutics (DTx)
- Patient engagement platforms
- Clinical decision support systems
We provide embedded and connected solutions that power and control physical medical devices, ensuring seamless integration and regulatory compliance.
Capabilities:
- Real-time data processing and analytics
- Device control and automation software
- Firmware and embedded systems
- Integration with EHR/EMR platforms
- Cybersecurity and data protection
With our expertise in medical device software, we deliver secure and compliant solutions. Our approach to software development for medical devices guarantees both clinical value and long-term product viability.
Our Success Stories
A health tech company partnered with us to develop a mobile application that supports real-time, data-driven insights into personal wellness. The solution combines multiple health data sources to help users make smarter lifestyle decisions.
Our team delivered a secure, scalable application with intelligent data processing, a user-friendly interface, and full compliance with industry standards. The project included a thorough discovery phase, end-to-end development, and robust quality assurance.
Key Highlights:
- Native mobile app with health data integration
- Discovery phase: product scoping and risk mitigation
- Real-time data synchronization and clean, intuitive UX
- On-time delivery aligned with business goals
- Scalable architecture supporting future growth and features
Medical Device Software Development Services We Offer
Navigating compliance, usability, and integration in medical device software development is complex. With our expertise, we provide end-to-end services to streamline and de-risk your product journey.
Mobile App Development
We build mobile interfaces for medical device software that provide access to SaMD data, supporting professionals and improving disease management.
Cloud Platform Development
We create secure, scalable cloud infrastructure for medical device software to enable remote access seamless device synchronization.
Advanced Analytics & Reporting
We integrate AI/ML into medical device software to analyze patient data, detect patterns, and predict health risks or treatment outcomes with accuracy.
IoT-Based Solutions
We connect physical devices via IoT for responsive medical device software that gathers and processes patient data.
Real-Time Health Monitoring
We develop solutions that enable tracking through medical device software, supporting early diagnosis and timely interventions.
Expertise & Certifications
Our Medical Device Software Development Process
Technologies We Use
Ideal for data-heavy medical solutions, Python supports fast prototyping, strong scientific libraries, and seamless integration with AI/ML components.
A secure, scalable backend framework that accelerates medical device software development while enforcing best practices for compliance and maintainability.
Efficient for building real-time features like health monitoring dashboards or device communication layers with non-blocking performance at scale.
Highly responsive UI framework perfect for dynamic SaMD interfaces and clinician portals with complex user interaction flows.
Lightweight and modular, Vue.js is well-suited for rapid development of patient-facing apps requiring high performance and flexibility.
Essential for cross-platform interactions, JavaScript ensures fluid integration between medical devices, cloud platforms, and user interfaces.
FAQ
We follow industry standards like ISO 13485, IEC 62304, and GDPR, and design our development process to align with FDA and MDR guidelines. Our QA practices ensure traceability, validation, and risk control at every stage.
