Custom medical device software development services

Custom Reliable Software Solutions for Modern Medical Devices

From wearable health monitors to advanced diagnostic systems, we specialize in building high-performance, regulation-ready software for medical devices. With deep expertise in healthcare and 8+ years of proven delivery, Celestial Infosoft helps medtech innovators bring compliant, scalable solutions to life faster and smarter.

medical device software development services provider company
Team

8+

Years of Expertise

Globe

350+

Our Global Clients

Tech mind

180+

IT professionals

Team Star

1000+

Completed Projects

\ Why we \

Why Choose Celestial Infosoft?

Trusted by startups and established medtech companies alike, Celestial Infosoft combines regulatory knowledge with modern tech expertise to deliver software that meets clinical standards and exceeds user expectations.

  • 8+ Years in Healthcare IT with proven success in developing secure and reliable medical software.

  • Regulatory Expertise with FDA, HIPAA, MDR, and IEC 62304 compliance from the ground up.

  • Certified Development Team skilled in ISO 13485-aligned processes and risk-managed delivery.

  • Multi-Platform Solutions including embedded firmware, mobile health apps, and cloud platforms.

  • Agile & Scalable Models tailored to medtech startups and enterprise device manufacturers.

  • End-to-End Partnership from concept, prototyping, and validation to post-launch support.

\ Our offering \

Our medical device software development services

Healthcare IT Modernization

Embedded Software for Medical Devices

We develop secure and compliant software for Class II and Class III medical devices, including:

  • Remote care devices (e.g., smart inhalers, insulin pens, ECG monitors).

  • Implanted or wearable diagnostics (e.g., neurostimulators, pacemakers).

  • Hospital-based systems for real-time monitoring and control.

These solutions enable continuous patient monitoring, early condition detection, and precision-based treatment delivery.

WearOS App

Software as a Medical Device (SaMD)

We specialize in building standalone software that meets regulatory definitions of a medical device. Platforms we build for:

  • Smartphones, tablets, and wearables

  • Desktops, web apps, and connected displays

Use cases include AI-assisted diagnosis, dose calculators, digital therapeutics, and personalized care assistants.

\ Who We Serve \

Healthcare Industry Expertise

Clinics and Hospitals

Hospitals and medical centers

Healthcare Software Providers

Healthcare software providers

Healthtech Startups

Healthtech startups

Home Care Providers

Home care providers

Mental Health Providers

Mental health providers

Medical Device Manufacturers

Medical device manufacturers

Pharmaceutical Companies

Pharmaceutical companies

Health Insurance Companies

Health insurance companies

Healthcare NGOs and Non-Profits

Healthcare NGOs and Non-Profits

Fitness and Wellness Companies

Fitness & wellness companies

Laboratories and Research Centers

Laboratories and research centers

Medical Biotech Companies

Medical biotech companies

\ Features \

Advanced Features & Modules We Deliver

telehealth app

Mobile Health Apps

We develop user-friendly mobile applications that provide patients and healthcare professionals with instant access to medical device data anytime, anywhere. These apps enable real-time monitoring, personalized alerts, and seamless communication, empowering better disease management and patient engagement on the go.

Business Intelligence & Analytics

AI-Powered Analytics

Our software harnesses the power of artificial intelligence and machine learning to analyze data collected from connected medical devices. This enables predictive insights such as early detection of health risks, trend forecasting, and personalized treatment recommendations, helping clinicians make informed decisions quickly and improving patient outcomes.

Cloud Software Development

Cloud Platform Integration

We build secure and compliant cloud platforms that aggregate data from multiple medical devices, providing centralized storage, processing, and analytics. This facilitates scalable data management, real-time synchronization, and remote access while ensuring data privacy and adherence to regulatory standards like HIPAA.

On-Demand Expert Pods

IoMT-Driven Tracking

Our solutions include Internet of Medical Things (IoMT) capabilities that track the location, usage, and maintenance status of medical devices in real-time. This helps healthcare providers optimize device utilization, streamline inventory management, reduce downtime, and ensure timely servicing and sanitization.

Advanced Analytics & Reporting

Real-Time Monitoring Dashboards

We create intuitive dashboards that offer healthcare teams a comprehensive view of patient vitals, medication adherence, and treatment progress in real-time. These visual tools support proactive care, enabling timely interventions and enhancing clinical workflow efficiency.

Replatforming

Secure Data Exchange

Our medical device software ensures seamless and secure exchange of health data between devices, EHR systems, and other healthcare platforms. By leveraging standardized protocols like HL7 and FHIR, we enable interoperability that supports coordinated care, reduces data silos, and enhances the overall healthcare ecosystem’s efficiency and accuracy.

\ Our Work \

Our healthcare projects showcase

Wearable Cardio Monitors into Hospital IT Ecosystems

Seamless Integration of Wearable Cardio Monitors into Hospital IT Ecosystems

Smart Insulin Pump

Ensuring Regulatory Compliance and Speedy FDA Approval for a Smart Insulin Pump

AI Driven Medical Device Software

Revolutionizing Remote Patient Monitoring with AI-Driven Medical Device Software

\ our process \

Our Medical Device Software Development Process

1. Discovery & Compliance Planning

We start by deeply analyzing your device goals, regulatory classification, and target users. Our experts create a risk-aware plan aligned with FDA, HIPAA, and IEC 62304 guidelines.

2. Future-Proof Architecture Design

We build scalable and modular software architectures to support easy device updates, integration, and long-term evolution.

3. User-Centric UX/UI Design

Our human-centered design ensures intuitive interfaces across devices, helping both patients and clinicians use the software confidently, regardless of tech proficiency.

4. Cross-Platform Software Development

Whether you need native mobile apps, cloud dashboards, or embedded firmware, we deliver performant, interoperable software using Agile or hybrid models.

5. Secure & Rigorous Testing

We apply Secure SDLC practices, automated test pipelines, code audits, and documentation for full traceability and certification-readiness.

6. Regulatory Submission Readiness

We support 510(k), CE marking, and MDR compliance through structured documentation and validation reporting, accelerating your time-to-market.

7. Device Connectivity & IoMT Integration

We ensure seamless, secure communication between your device and cloud/server infrastructure, covering everything from Bluetooth pairing to real-time alerts.

8. Ongoing Support & Software Evolution

Our post-launch services include performance monitoring, compliance updates, bug fixes, and new feature development as your product scales.

\ You're Just One call away \

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\ Few Words \

Clients who trust in our service

"Their deep understanding of the healthcare industry helped us create a secure, user-friendly platform that improved patient management."

Dr. Emily T. USA

"Celestial Infosoft delivered a seamless EHR solution tailored to our clinic’s needs. Their team was responsive, detail-oriented, and ensured full HIPAA compliance throughout the project."

HarmonyCare Clinic USA

"Celestial Infosoft built us a HIPAA-compliant telehealth platform with AI-assisted triage. The system has enabled us to serve more patients, more securely, and with greater efficiency."

Dr. Anderson Australia

“Our patient portal project was a huge success thanks to Celestial Infosoft. They not only met our strict compliance requirements but also created a user-friendly and secure platform that both patients and staff love.”

WellPath Clinics Australia

"We partnered with Celestial Infosoft to develop a telehealth platform for our mental wellness startup. The outcome exceeded expectations, the platform is fast, secure, and loved by both therapists and users."

Dr. Lukas Germany

\ Our Recognition \

Trusted and respected globally

Clutch Top developers badge 2022
Outsourcing 100 2024 Award
Inc 5000 2025 Award
Clutch Top 1000 companies 2023
Top Software developers 2022

\ FAQs \

Frequently Asked Questions

We embed compliance with FDA, MDR, HIPAA, and IEC 62304 standards throughout the development lifecycle. This includes rigorous documentation, risk management, and validation processes to meet all regulatory requirements and support smooth market approval.

Yes, our solutions are designed for seamless interoperability. We use standard healthcare protocols like HL7 and FHIR to integrate with EHRs, lab systems, and a wide range of medical devices, ensuring smooth data flow and unified patient care.

Data security is paramount. We implement robust encryption, access controls, and continuous security testing to protect sensitive health data. Our solutions comply with HIPAA, GDPR, and other relevant privacy regulations to safeguard patient information.

We adapt our approach based on project needs, ranging from traditional Waterfall for well-defined scopes to Agile and Scrum for iterative development. This flexibility allows us to deliver high-quality products efficiently while accommodating evolving requirements.

Every great project starts with a good conversation

We are curious to discuss your dream web project!

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